Cleared Traditional

K972666 - TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY

K972666 is the FDA 510(k) clearance for TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY by Hybritech, Inc.. It is a Class 2 Chemistry device (product code CIN) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K972666 · Hybritech, Inc. · Chemistry device
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Sep 1997
Decision
57d
Days
Class 2
Risk

K972666 is an FDA 510(k) clearance for the TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY. Classified as Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (product code CIN), Class II - Special Controls.

Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on September 11, 1997 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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 Hybritech, Inc. devices

Submission Details

510(k) Number K972666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1997
Decision Date September 11, 1997
Days to Decision 57 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
31d faster than avg
Panel avg: 88d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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 - CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

All 17
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