Auto/Stat Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K780512 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Glyco-Gel Test Kit

  Class II

  FDA 510(k) K820279 Active Cleared 8 Apr 1982

• Glycotest II Glyhb Assay Kit

  Class II

  FDA 510(k) K895661 Active Cleared 7 Dec 1989

• Triglyceride C-37 Rapid Stat Kit

  Class I

  FDA 510(k) K780825 Active Cleared 26 May 1978

• Bilirubin Rapid Stat Kit

  Class II

  FDA 510(k) K780826 Active Cleared 26 May 1978

• Uric Acid Rapid Stat Kit

  Class I

  FDA 510(k) K780827 Active Cleared 13 Jun 1978

• Cholesterol Rapid Slat Kit Hdl

  Class I

  FDA 510(k) K780331 Active Cleared 6 Apr 1978

See all devices from Pierce Chemical Co. →

• What is the Auto/Stat Kit used for?

  The Auto/Stat Kit is designed for the colorimetric determination of glucose in biological fluids. It uses enzymatic reactions to produce measurable absorbance changes, allowing for quantitative analysis of glucose levels. This makes it suitable for clinical chemistry laboratories performing routine glucose testing.

• Is the Auto/Stat Kit single-use or reusable?

  The Auto/Stat Kit is explicitly supplied as a single-use reagent system. This design ensures consistency and reliability for each test, reducing the risk of cross-contamination or degradation of reagents over repeated use. After use, the kit should be discarded according to laboratory protocols.

• What storage conditions are required for the Auto/Stat Kit?

  The kit does not require special storage conditions beyond those outlined in the accompanying instructions. While it is not sterile, proper storage—such as in a cool, dry place away from direct sunlight—is recommended to maintain reagent stability. Always follow the manufacturer’s guidelines to ensure accurate and reliable test results.

• Is the Auto/Stat Kit approved for use in MRI environments?

  There is no indication in the provided data that the Auto/Stat Kit is safe or approved for use in MRI environments. Since it is a reagent-based diagnostic system, MRI compatibility is not applicable. Always verify device-specific safety guidelines before use in any clinical setting.

• What regulatory clearance does the Auto/Stat Kit hold?

  The Auto/Stat Kit was cleared under the FDA’s 510(k) process, specifically clearance number K780512, in 1978. It is classified as a Class II device under regulation number 862.1345 and falls under the Clinical Chemistry advisory committee. This clearance indicates it is substantially equivalent to a predicate device for its intended use.