Concise source Source status · 1 documents · Completeness: 34%
- Bando_avviso_esplorativo_260416_092216.pdf (avviso, 6 pp.)
ℹ️ Concise source (notice/market survey or single annex): data such as CIG, guarantees, ANAC, stamp duty appear only in the full tender's disciplinare, not yet available here. 'Not stated' fields reflect the document, not a gap in the analysis.
🔴 NO-GO
Focus: POCT; coagulazione POCT; immunometria/test rapidi · Deadline: expired · Exclusivity risk: high
Deadline already expired (notice 16/04/2026, estimated deadline ~26/04/2026) and proprietary consumables tied to installed Abbott analyzers: strong non-substitutability risk, participation possible only with documented equivalent products.
🎯 Merit only (ignore deadline): NO-GO — NON-SUBSTITUTABILITY verification on proprietary Abbott consumables (i-STAT/Stat Alinity): contestable only by demonstrating equivalence with compatible products, very difficult.
TENDER ANALYSIS No. 2026-04_Bando_esplorativo
Document generated on 04/06/26 15:24
TENDER IDENTIFICATION DATA
| TENDER SUBJECT | Exploratory notice for the verification of non-substitutability (infungibility) preparatory to a negotiated procedure without prior publication of a call for tenders (art. 76, para. 2, lett. b, Legislative Decree 36/2023) for the supply of consumables required by the analyzer for the diagnosis of head trauma and ACS (Stat Alinity, code 02R6001) and for ACT coagulation (portable analyzer i-STAT1 300, code 04P7501)Source: Bando_avviso_esplorativo_260416_092216.pdf: pagina 1 |
| CONTRACTING AUTHORITY | ASL ROMA 3 - UOC Procurement, Via Casal Bernocchi 73, 00125 Rome (G.B. Grassi Hospital)Source: Bando_avviso_esplorativo_260416_092216.pdf: pagina 2 |
| CIG (tender ID) | Not stated |
| PROCEDURE TYPE | Exploratory notice / market survey for the verification of non-substitutability, preparatory to a negotiated procedure without prior publication of a call for tenders pursuant to art. 76, para. 2, lett. b) of Legislative Decree 36/2023Source: Bando_avviso_esplorativo_260416_092216.pdf: pagina 1 |
| PLATFORM | S.TEL.LA. (Telematic Procurement System of the Lazio Region)Source: Bando_avviso_esplorativo_260416_092216.pdf: pagina 2 |
| PLACE OF PERFORMANCE | G.B. Grassi Hospital - Emergency Department/Emergency Medicine and UOC Cardiology, Rome (ASL Roma 3)Source: Bando_avviso_esplorativo_260416_092216.pdf: pagina 1 |
| AWARD CRITERION | Not stated |
| BID SUBMISSION DEADLINE | By 12:00 noon of the 10th (tenth) day following the publication of the notice (exact date not stated; notice dated 16/04/2026 according to document references, estimated deadline around 26/04/2026, postponed to the first available non-holiday day)Source: Bando_avviso_esplorativo_260416_092216.pdf: pagina 2 |
| TOTAL AMOUNT | € 99.450,00 + 22% VAT (estimated annual amount)Source: Bando_avviso_esplorativo_260416_092216.pdf: pagina 1 |
| PNRR (recovery funds) | Not stated |
PARTICIPATION REQUIREMENTS
| ELIGIBILITY REQUIREMENTS | Possession of general eligibility requirements pursuant to artt. 94, 95 and 98 of the Code (absence of grounds for exclusion under artt. 94 and 95 of Legislative Decree 36/2023) and registration in the Business Register / Register of artisan enterprises for activities relevant to the subject of the noticeSource: Bando_avviso_esplorativo_260416_092216.pdf: pagina 3 |
| ECONOMIC CAPACITY | Not stated |
| TECHNICAL CAPACITY | Not stated |
| SOA CATEGORY | Not stated |
| CREDIT LICENCE | Not stated |
| ADDITIONAL REQUIREMENTS | Not stated |
| WHITE LIST | Not stated |
PRELIMINARY OBLIGATIONS
| BID BOND | Not stated |
| ANAC FEE | Not stated |
| SITE INSPECTION | Not stated |
| SAMPLING | Not stated |
| TIMESTAMP / DIGITAL SIGNATURE | Not stated |
| TECHNICAL OFFER | At this stage it is not permitted to submit offers, quotations or economic evaluations. An expression of interest is required (annex 1) with: technical data sheets of the consumables in Italian; product code, CND, medical device registry number and Basic UDI-DI; detailed declaration of performance equivalence; scientific studies supporting functional equivalenceSource: Bando_avviso_esplorativo_260416_092216.pdf: pagina 3 |
| STAMP DUTY | Not stated |
| LABOUR CONTRACT (CCNL) | Not stated |
| ACCELERATION BONUS | Not stated |
| SUBCONTRACTING | Not stated |
| RELIANCE (avvalimento) | Not stated |
| RTI / CONSORTIUM | Not stated |
| CLARIFICATIONS DEADLINE | Questions via the S.TEL.LA. platform no later than 6 (six) days before the deadline for submitting expressions of interest; answers provided at least 2 (two) days before the deadlineSource: Bando_avviso_esplorativo_260416_092216.pdf: pagina 4 |
| FVOE (virtual file) | Not stated |
Custom questions
Is the CPV stated?
No, the CPV is not stated in the document.
Is this an open tender to which an offer can be submitted?
No: it is an exploratory notice / market survey to verify non-substitutability. No tender procedure has been launched and it is not permitted to submit offers or economic quotations; only an expression of interest with proof of performance equivalence is to be submitted. Source: Bando_avviso_esplorativo_260416_092216.pdf: pagina 3
Who is the operator indicated as the potential exclusive supplier?
Abbott S.r.l., supplier of the Stat Alinity (code 02R6001) and i-STAT1 300 (code 04P7501) analyzers and of the related consumables. Source: Bando_avviso_esplorativo_260416_092216.pdf: pagina 1
Is a digital signature required?
Yes: the expression of interest must be signed and digitally signed by the Owner or Legal Representative, with an attached copy of a valid identity document of the signatory. Source: Bando_avviso_esplorativo_260416_092216.pdf: pagina 3
TECHNICAL ANALYSIS
Subject: Exploratory notice for the verification of non-substitutability (negotiated procedure without a call for tenders, art. 76 para. 2 lett. b Legislative Decree 36/2023) for the supply of consumables for analyzers dedicated to the diagnosis of head trauma and ACS and to ACT coagulationTotal base amount: € 99.450,00 + 22% VAT (estimated annual)No. of lots: 1
LOT 1 — Consumables for Abbott analyzers (head trauma/ACS and ACT coagulation) - single lot
| CIG | Not stated |
| Description / what it is | Supply of reagents and consumable cartridges required to operate the analyzers already in use at the hospital: the Stat Alinity system (code 02R6001) for the diagnosis of head trauma and acute coronary syndromes (ACS) in the Emergency Department/Emergency Medicine, and the portable POCT analyzer i-STAT1 300 (code 04P7501) for ACT coagulation in Cardiology. In practice, the consumables that allow the tests to be performed on the already installed Abbott instruments are purchased. |
| System / instrumentation | Abbott Stat Alinity Analyzer (code 02R6001) for head trauma/ACS immunoassay; Abbott i-STAT1 300 (code 04P7501), portable POCT analyzer for ACT coagulation. Equipment supplied by Abbott S.r.l. |
| Base amount | € 99.450,00 + 22% VAT (estimated annual amount; at this stage economic quotations are not permitted) |
| Volumes | 1750 pcs HS-TnI; 1650 pcs TBI (GFAP/UCH-L1); 250 pcs ACT-K; 150 pcs PT Plus (estimated annual quantities) |
| Duration | Not stated |
| Required tests | - i-STAT HS-TnI (high-sensitivity Troponin I) - cartridge code 09P8125, qty 1750 pcs
- TBI - Traumatic Brain Injury (biomarkers GFAP and UCH-L1) - code 0350925, qty 1650 pcs
- ACT-K (ACT Kaolin) - code 03P8725, qty 250 pcs
- PT Plus (PT and INR) - code 03P89-50, qty 150 pcs
|
| Technical requirements | - Technical data sheets of the consumables in Italian (or translated)
- Product code, relevant CND, medical device registry number (Ministerial Decree 11/05/2023) and Basic UDI-DI code on the first level of packaging
- Detailed declaration of performance equivalence: the characteristics of the consumable must equivalently meet the therapeutic needs for which it is required
- Scientific studies or other material supporting the declared functional equivalence
|
| Sampling | Not stated (technical data sheets, registry/UDI data and scientific studies are requested, not physical samples) |
| Notes | ATTENTION - high exclusivity/non-substitutability risk: the consumables (HS-TnI, TBI GFAP/UCH-L1, ACT-K, PT Plus cartridges) are proprietary Abbott codes designed exclusively for the already installed Abbott Stat Alinity and i-STAT analyzers. The notice serves precisely to verify whether there are operators able to offer FUNCTIONALLY EQUIVALENT products; it is not an open tender and no economic offers are submitted. Firsteck can compete ONLY if it markets/manufactures equivalent consumables compatible with the i-STAT/Stat Alinity platform, or an alternative solution that delivers the same clinical result (POCT HS troponin, head trauma biomarkers GFAP/UCH-L1, ACT/PT-INR POCT) and is willing to document the equivalence with technical data sheets and scientific studies. Without its own line of compatible consumables or accredited alternative POCT systems, participation is effectively precluded by the dependence on the Abbott instrument. |
| Sources | - Bando_avviso_esplorativo_260416_092216.pdf: pagina 1
- Bando_avviso_esplorativo_260416_092216.pdf: pagina 3
|
Assessment for Firsteck Bio
The subject nominally falls within Firsteck's focus areas (immunoassay/rapid tests for HS troponin and head trauma biomarkers, POCT coagulation with ACT and PT/INR). However, this is a non-substitutability verification notice for proprietary consumables tied to already installed Abbott instruments (Stat Alinity, i-STAT): the exclusivity risk is high and participation is only possible by demonstrating performance equivalence with compatible/alternative products and related scientific studies. Furthermore, as of today (04/06/2026) the deadline (12:00 noon of the 10th day after the publication of 16/04/2026, ~26/04/2026) has largely expired. Unless Firsteck already has equivalent consumables compatible with the Abbott platform, the tender is of little practical interest.