← Product Code [GJS](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJS) · K132722

# HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) (K132722)

_Instrumentation Laboratory CO · GJS · Jan 22, 2014 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJS/K132722

## Device Facts

- **Applicant:** Instrumentation Laboratory CO
- **Product Code:** [GJS](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJS.md)
- **Decision Date:** Jan 22, 2014
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 864.7750
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

HemosIL RecombiPlasTin 2G is a high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibringgen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

## Device Story

HemosIL RecombiPlasTin 2G is an in vitro diagnostic reagent used for coagulation testing. This modification updates on-board stability claims for the 8mL reagent vial. Stability on ACL Futura/ACL Advance systems changed from 10 days to 3 days at 15°C; stability on ACL ELITE and ACL TOP systems changed from 10 days to 4 days at 15°C. Device remains unchanged in fundamental scientific technology, intended use, and physical characteristics. Modification verified via risk analysis (ISO 14971) and design control activities.

## Clinical Evidence

No clinical data provided; device is a reagent for in vitro diagnostic use.

## Technological Characteristics

Reagent based on recombinant human tissue factor (RTF). Designed for use on IL Coagulation Systems. Formulated as a liquid reagent in 8 mL vials.

## Regulatory Identification

A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

## Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER: K132722

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device (HemosIL RecombiPlasTin 2G, k070005).
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for modification to on-board stability claim for RecombiPlasTin 2G reagent (8mL vial) from 10 days at 15°C to 3 days at 15°C on the ACL Futura/ACL Advance. On-board stability also changed from 10 days at 15°C to 4 days at 15°C on the ACL ELITE and ACL TOP devices.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and on-board stability. (pp.61-62 of 178)
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. The risk analysis was performed using a "RAW" (Risk Analysis Worksheet). The Risk Analysis Summary report is included on page 42 of 78, and fulfills the requirements of ISO 14971.
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied. Verification and validation activities and summary, p.50 of 78 and S001, p.17 of 175.
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met. (pp.46-48)
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. (pp.46-48)

A Truthful and Accurate Statement (p.35 of 78), a 510(k) Statement (S001 p.11 of 175) and the Indications for Use Enclosure (S001 provided via email).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJS/K132722](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJS/K132722)

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