Cleared Traditional

K961573 - TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY

K961573 is the FDA 510(k) clearance for TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY by Hybritech, Inc.. It is a Class 2 Chemistry device (product code CIN) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K961573 · Hybritech, Inc. · Chemistry device
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Aug 1996
Decision
118d
Days
Class 2
Risk

K961573 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 August 19, 1996 after a review of 118 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 K961573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1996
Decision Date August 19, 1996
Days to Decision 118 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
30d slower than avg
Panel avg: 88d · This submission: 118d
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
Devices cleared under the same product code (CIN) and FDA review panel - the closest regulatory comparables to K961573.
ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
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OPUS BONE ALP
K964764 · Behring Diagnostics, Inc. · Jan 1997
RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT
K934013 · Isolab, Inc. · Apr 1994
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
K930810 · Hybritech, Inc. · Jan 1994
TITAN GEL ALKALINE PHOSPHATASE (HR)
K921578 · Helena Laboratories · Sep 1992