Precise HCG

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

Full name

Precise Tm Hcg

510(k) Number

K915197 ↗

FDA Product Code

JHI

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Iq TT4 Assay

  Class II

  FDA 510(k) K931295 Active Cleared 20 Jul 1993

• Precise Strep a

  Class I

  FDA 510(k) K923673 Active Cleared 28 Sep 1992

• Iq Tuptake Assay

  Class II

  FDA 510(k) K931294 Active Cleared 22 Jul 1993

• Becton Dickinson Thyroid Stimulating Hormone Syste

  Class II

  FDA 510(k) K925132 Active Cleared 28 Dec 1992

• Iq Immunochemistry Sistem; Iq Tsh Assay

  Class I

  FDA 510(k) K923060 Active Cleared 15 Sep 1992

• Qtest(R) Strep

  Class I

  FDA 510(k) K935667 Active Cleared 21 Apr 1994

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• What is the Precise HCG device used for?

  The Precise HCG is a qualitative immunoassay designed to detect human chorionic gonadotropin (hCG) in urine or serum samples. It uses lateral flow technology to provide a visual result, helping confirm pregnancy status in clinical settings. The device identifies the presence of hCG, a hormone produced during pregnancy, making it useful for early pregnancy verification.

• Is the Precise HCG device single-use or reusable?

  The Precise HCG device is intended for single-use only. This design ensures accuracy and safety, as reuse could compromise the integrity of the test results or introduce contamination. Each device is packaged individually for this purpose.

• What are the sterility and storage conditions for the Precise HCG?

  The Precise HCG device is supplied as non-sterile, meaning it is not intended for sterile procedures or invasive use. Storage conditions are not explicitly detailed in the provided data, so it is recommended to follow standard laboratory protocols for handling non-sterile diagnostic devices. Always store in a clean, dry environment away from direct sunlight or extreme temperatures.

• What regulatory pathway does the Precise HCG follow?

  The Precise HCG device is classified under FDA 510(k) clearance, specifically as substantially equivalent to a predicate device. It falls under regulatory category 862.1155 and has the product code JHI. The device is intended for prescription use only and is approved for clinical chemistry settings, adhering to standard laboratory protocols.

• Are there different models or sizes available for the Precise HCG?

  The provided data does not specify multiple models or sizes for the Precise HCG device. It is listed under a single product name with various FEI numbers, which may correspond to different lot or batch identifiers rather than distinct models. For precise details on variations, refer to the manufacturer’s documentation or contact Becton Dickinson Advanced Diagnostics.