← Product Code [JKA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA) · K960857

# GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR (K960857)

_Greiner America, Inc. · JKA · Aug 30, 1996 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA/K960857

## Device Facts

- **Applicant:** Greiner America, Inc.
- **Product Code:** [JKA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA.md)
- **Decision Date:** Aug 30, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1675
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

The Greiner Vacuette™ blood collection tube with anticoagulant lithium heparin and gel separator is an evacuated blood collection device containing lithium heparin, an anticoagulant additive, and an inert polymeric barrier material. The product is intended for use in holding and separating blood plasma from the cellular components of blood.

## Device Story

Evacuated blood collection tube; contains lithium heparin anticoagulant and inert polymeric gel separator; used for plasma separation from cellular blood components. Operated by clinical laboratory personnel; blood sample drawn into tube via vacuum; centrifugation separates plasma from cells. Healthcare providers use separated plasma for clinical chemistry analysis. Benefits include standardized sample collection and efficient plasma isolation for diagnostic testing.

## Clinical Evidence

Bench testing only. Comparative study of paired samples collected in Greiner Vacuette™ and Becton Dickinson Vacutainer® tubes. Evaluated 23 analytes and 3 hormones. Results showed good correlation with coefficients ranging from 0.168 to 0.999.

## Technological Characteristics

Evacuated blood collection tube; clear plastic construction; contains lithium heparin anticoagulant and inert polymeric barrier gel. Standalone device.

## Regulatory Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

## Predicate Devices

- Becton Dickinson Vacutainer® brand lithium heparin additive tube ([K944566](/device/K944566.md))

## Submission Summary (Full Text)

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K960857
AUG 30 1996

# I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Greiner America, Inc. ("Greiner") is submitting a 510(k) premarket notification for its Greiner Vacuette™ blood collection tube with anticoagulant lithium heparin and gel separator. The Greiner Vacuette™ blood collection tube with lithium heparin and gel separator is an evacuated blood collection device containing lithium heparin, an anticoagulant additive, and an inert polymeric barrier material. The product is intended for use in holding and separating blood plasma from the cellular components of blood.

Greiner is claiming substantial equivalence to Becton Dickinson's Vacutainer® brand lithium heparin additive tube (K944566). Both blood collection tubes have the same intended use and contain the same stopper material, additive and separator. The tube material for the Greiner product is clear plastic, whereas the material for the Becton Dickinson product is glass. The equivalency of assay results was evaluated by testing paired samples collected in Greiner Vacuette™ tubes and Becton Dickinson Vacutainer® tubes. Test results from paired samples for 23 analytes and 3 hormones were evaluated. Good correlation was observed, with correlation coefficients ranging from 168 to 0.900.

Greiner's 510(k) has been submitted on February 27, 1996, by Ed Maier, Managing Director, Greiner America, Inc., 7 Henry Court, Wilmington, Delaware, 19808 (302/998-8046).

01/239242.1

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA/K960857](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA/K960857)

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