Cleared Traditional

QUANTECH TOTAL B-HCG ASSAY (K990258) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K990258 · Quantech , Ltd. · Chemistry device
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Dec 1999
Decision
328d
Days
Class 2
Risk

K990258 is an FDA 510(k) clearance for the QUANTECH TOTAL B-HCG ASSAY. Classified as Test, Immunoassay, Biosensor, Hcg (product code NAL), Class II - Special Controls.

Submitted by Quantech , Ltd. (Northridge, US). The FDA issued a Cleared decision on December 21, 1999 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Quantech , Ltd. devices

Submission Details

510(k) Number K990258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1999
Decision Date December 21, 1999
Days to Decision 328 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
240d slower than avg
Panel avg: 88d · This submission: 328d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NAL Test, Immunoassay, Biosensor, Hcg
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.