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PregTell I

by Central Biological Co.

510(k) K792027

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK792027 Date30 Oct 1979ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JHJ
Device Class
Class II
Regulation
21 CFR Part 862.1155
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PregTell I is an agglutination method device for detecting human chorionic gonadotropin (hCG), a biomarker used to confirm pregnancy. Classified under the Clinical Chemistry specialty, it employs a visual agglutination assay to identify hCG in urine or serum samples, distinguishing between positive and negative results based on particle clumping.

This device is supplied as a single-use diagnostic reagent and is intended for in vitro use in clinical chemistry laboratories. It requires no special storage conditions beyond those specified in the accompanying instructions, though sterility is maintained via standard manufacturing practices. The PregTell I was cleared under FDA 510(k) K792027 (Traditional pathway) and falls under device class II, adhering to regulatory standards for agglutination-based diagnostic assays.

Other devices from Central Biological Co.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the PregTell I used for?

    The PregTell I is designed to detect human chorionic gonadotropin (hCG) in urine or serum samples, confirming pregnancy through a visual agglutination assay. This method identifies hCG by observing particle clumping, distinguishing between positive and negative results.

  • How is the PregTell I supplied and intended for use?

    The PregTell I is supplied as a single-use diagnostic reagent intended exclusively for in vitro use in clinical chemistry laboratories. It is not reusable and must be used according to the provided instructions.

  • What sterility and storage requirements does the PregTell I have?

    Sterility of the PregTell I is maintained through standard manufacturing practices. No special storage conditions are required beyond those outlined in the accompanying instructions, ensuring usability within specified guidelines.

  • Is the PregTell I reusable or single-use?

    The PregTell I is explicitly designed as a single-use diagnostic reagent. Each unit is intended for one test only, preventing cross-contamination and ensuring accurate results.

  • What regulatory pathway was followed for the PregTell I?

    The PregTell I was cleared under the FDA’s 510(k) pathway (K792027) using the Traditional route, classified as substantially equivalent to a predicate device. It adheres to regulatory standards for agglutination-based diagnostic assays in Clinical Chemistry.