← Product Code [JKA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA) · K971239

# GREINER VACUETTE BLOOD COLLECTION TUBE (K971239)

_Greiner America, Inc. · JKA · May 12, 1997 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA/K971239

## Device Facts

- **Applicant:** Greiner America, Inc.
- **Product Code:** [JKA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA.md)
- **Decision Date:** May 12, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1675
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

Greiner Vacuette® blood collection tube with EDTA and sodium fluoride; and (2) its Greiner Vacuette® blood collection tube with potassium oxalate and sodium fluoride. Both Greiner Vacuette® blood collection tubes are evacuated blood collection devices intended for use in testing glucose and lactate levels in blood.

## Device Story

Evacuated blood collection tubes; used for glucose and lactate testing. Input: venous blood sample. Operation: vacuum-based collection; additives (EDTA/sodium fluoride or potassium oxalate/sodium fluoride) stabilize blood for laboratory analysis. Output: blood sample contained in tube for clinical laboratory processing. Used in clinical settings by phlebotomists or healthcare personnel. Benefit: standardized sample collection for accurate diagnostic testing.

## Clinical Evidence

Bench testing only. Comparative study of paired samples collected in Greiner Vacuette tubes versus Becton Dickinson Vacutainer tubes. Glucose assay results evaluated for correlation; good correlation observed.

## Technological Characteristics

Evacuated blood collection tubes; clear plastic construction; additives include EDTA, sodium fluoride, and potassium oxalate. Stopper material identical to predicate. Non-electronic; no software.

## 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's Vacutainer® tube with sodium EDTA/sodium fluoride
- Becton Dickinson's Vacutainer® tube with sodium fluoride and potassium oxalate

## Submission Summary (Full Text)

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K971239

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

MAY 12 1997

Greiner America, Inc. ("Greiner") is submitting a 510(k) premarket notification for: (1) its Greiner Vacuette® blood collection tube with EDTA and sodium fluoride; and (2) its Greiner Vacuette® blood collection tube with potassium oxalate and sodium fluoride. Both Greiner Vacuette® blood collection tubes are evacuated blood collection devices intended for use in testing glucose and lactate levels in blood.

For the above two tubes, Greiner is claiming substantial equivalence to, respectively: (1) Becton Dickinson's Vacutainer® tube with sodium EDTA/sodium fluoride; and (2) Becton Dickinson's Vacutainer® tube with sodium fluoride and potassium oxalate. Both the Greiner and Becton Dickinson blood collection tubes have the same intended use and contain the same stopper material and additives. The tube material for the Greiner product is clear plastic, and the material for the Becton Dickinson product is glass. The equivalency of assay results of the two tubes was evaluated by testing paired samples collected in Greiner Vacuette® EDTA/sodium fluoride tubes and Becton Dickinson Vacutainer® sodium EDTA and sodium fluoride tubes, and paired samples collected in Greiner Vacuette® potassium oxalate and sodium fluoride tubes and Becton Dickinson potassium oxalate and sodium fluoride tubes. Glucose assay results from paired samples for each tube type were evaluated and good correlation was observed.

Greiner's 510(k) has been submitted on April 1, 1997, by Ed Maier, Managing Director, Greiner America, Inc., P.O. Box 953279, Lake Mary, Florida 32795/3279 (407/333-2800).

VA01A/76553.1

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA/K971239](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA/K971239)

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