Cleared Traditional

K003178 - ELECSYS HCG AND BETA TEST SYSTEM

K003178 is the FDA 510(k) clearance for ELECSYS HCG AND BETA TEST SYSTEM by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code DHA) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K003178 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
64d
Days
Class 2
Risk

K003178 is an FDA 510(k) clearance for the ELECSYS HCG AND BETA TEST SYSTEM. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 14, 2000 after a review of 64 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K003178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2000
Decision Date December 14, 2000
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
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 36
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K003178.
NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY
K042676 · Nichols Institute Diagnostics · Dec 2004
IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
K033234 · Diagnostic Products Corp. · Dec 2003
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 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