Cleared Traditional

TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (K930810) - FDA 510(k) Clearance

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

K930810 · Hybritech, Inc. · Chemistry device
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Jan 1994
Decision
328d
Days
Class 2
Risk

K930810 is an FDA 510(k) clearance for the TANDEM-R OSTASE IMMUNORADIOMETRIC 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 January 11, 1994 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 862.1050 - 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: 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 Hybritech, Inc. devices

Submission Details

510(k) Number K930810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1993
Decision Date January 11, 1994
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 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

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