Cleared Traditional

K961573 - TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY

K961573 is an FDA 510(k) clearance for TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY, manufactured by Hybritech, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K961573

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.

CIN Device Classification - Class 2, Special Controls

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 22
Devices cleared under the same product code (CIN) and FDA review panel - the closest regulatory comparables to K961573.
ALKPHASE-B ASSAY KIT
K981373 · Metra Biosystems, Inc. · May 1998
TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY
K972666 · Hybritech, Inc. · Sep 1997
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