Cleared Traditional

K991532 - DRX QT. HCG

K991532 is the FDA 510(k) clearance for DRX QT. HCG by Metrika, Inc.. It is a Class 2 Chemistry device (product code DHA) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K991532 · Metrika, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
137d
Days
Class 2
Risk

K991532 is an FDA 510(k) clearance for the DRX QT. HCG. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Metrika, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on September 17, 1999 after a review of 137 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Metrika, Inc. devices

Submission Details

510(k) Number K991532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1999
Decision Date September 17, 1999
Days to Decision 137 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 88d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHA System, Test, Human Chorionic Gonadotropin
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 - DHA System, Test, Human Chorionic Gonadotropin

All 43
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K991532.
ELECSYS HCG AND BETA TEST SYSTEM
K003178 · Roche Diagnostics Corp. · Dec 2000
ELECSYS HCG TEST SYSTEM
K002148 · Roche Diagnostics Corp. · Aug 2000
IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5
K994085 · Diagnostic Products Corp. · Jan 2000
IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6
K990222 · Diagnostic Products Corp. · Feb 1999
ABBOTT ARCHEITECT TOTAL B-HCG
K983424 · Abbott Laboratories · Dec 1998
BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST
K974425 · Princeton BioMeditech Corp. · Dec 1997