Cleared Traditional

K042676 - NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUM...

K042676 is the FDA 510(k) clearance for NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUM... by Nichols Institute Diagnostics. It is a Class 2 Chemistry device (product code DHA) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K042676 · Nichols Institute Diagnostics · Chemistry device
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Dec 2004
Decision
79d
Days
Class 2
Risk

K042676 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (San Clemente, US). The FDA issued a Cleared decision on December 17, 2004 after a review of 79 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 Nichols Institute Diagnostics devices

Submission Details

510(k) Number K042676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2004
Decision Date December 17, 2004
Days to Decision 79 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 88d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

California Department of Health Services
ALFREDO QUATTRONE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DHA System, Test, Human Chorionic Gonadotropin

All 42
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K042676.
VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS
K063720 · Ortho-Clinical Diagnostics · Apr 2007
DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632
K063754 · Dade Behring, Inc. · Feb 2007
STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK
K060548 · Dade Behring, Inc. · Apr 2006
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 AND BETA TEST SYSTEM
K003178 · Roche Diagnostics Corp. · Dec 2000