Cleared Traditional

K994085 - IMMULITE TURBO HCG

K994085 is the FDA 510(k) clearance for IMMULITE TURBO HCG by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code DHA) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K994085 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
56d
Days
Class 2
Risk

K994085 is an FDA 510(k) clearance for the IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5. 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 January 28, 2000 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K994085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1999
Decision Date January 28, 2000
Days to Decision 56 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
32d faster than avg
Panel avg: 88d · This submission: 56d
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 K994085.
STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD
K003696 · Dade Behring, Inc. · Jan 2001
ELECSYS HCG AND BETA TEST SYSTEM
K003178 · Roche Diagnostics Corp. · Dec 2000
ELECSYS HCG TEST SYSTEM
K002148 · Roche Diagnostics Corp. · Aug 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