Cleared Traditional

K842692 - QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT

K842692 is the FDA 510(k) clearance for QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT by Quidel Corp.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K842692 · Quidel Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1984
Decision
56d
Days
Class 2
Risk

K842692 is an FDA 510(k) clearance for the QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Quidel Corp. (Washington, US). The FDA issued a Cleared decision on September 5, 1984 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Quidel Corp. devices

Submission Details

510(k) Number K842692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1984
Decision Date September 05, 1984
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 118
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K842692.
STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY
K850570 · American Dade · Apr 1985
QUEST BETA HCG ENZYME IMMUNOASSAY KIT
K844082 · Quidel Corp. · Nov 1984
EPSILON HCG TEST KIT MONOCLONAL
K842654 · Beckman Instruments, Inc. · Oct 1984
CA-1511, IN VITRO RADIOIMMUNOASSAY
K841821 · Travenol Laboratories, S.A. · Jun 1984
VENTREZYME BETA-HCG IMMUNOASSAY HCG
K841081 · Ventrex Laboratories, Inc. · May 1984
COATED TUBE HCG IMMUNOASSAY HCG
K841023 · Ventrex Laboratories, Inc. · May 1984