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HCG RIA

by Syncor Intl. Corp. 510(k)

Active United States

510(k) K833851

Overview

This device is a visual pregnancy human chorionic gonadotropin (hCG) test system, classified as a Class II medical device under regulation number 862.1155. It is designed for the detection of hCG in urine or serum samples to aid in the determination of pregnancy.

The device is supplied for prescription use and was cleared through the FDA 510(k) process under K833851 with a traditional clearance pathway. It is manufactured by Syncor Intl. Corp. and is intended for use in clinical laboratory settings as part of clinical chemistry testing.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK833851 Date19 Mar 1984ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

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Questions

  • What is the HCG RIA test system used for?

    The HCG RIA test system is designed for the detection of human chorionic gonadotropin (hCG) in urine or serum samples to aid in the determination of pregnancy, as it is a visual pregnancy test system intended for clinical laboratory use.

  • How is the HCG RIA device supplied and for what setting is it intended?

    The device is supplied for prescription use and is intended for use in clinical laboratory settings as part of clinical chemistry testing, meaning it is not available over-the-counter and requires a healthcare provider's order.

  • What regulatory pathway was used for the HCG RIA device clearance?

    The HCG RIA device was cleared through the FDA 510(k) process under submission K833851 with a traditional clearance pathway, indicating it was found substantially equivalent to a legally marketed predicate device.