Cleared Traditional

K990222 - IMMULITE HCG

K990222 is the FDA 510(k) clearance for IMMULITE HCG by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code DHA) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K990222 · Diagnostic Products Corp. · Chemistry device
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Feb 1999
Decision
32d
Days
Class 2
Risk

K990222 is an FDA 510(k) clearance for the IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on February 26, 1999 after a review of 32 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K990222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1999
Decision Date February 26, 1999
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
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 38
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K990222.
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
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
ELECSYS HCG ASSAY
K961487 · Boehringer Mannheim Corp. · Jun 1996