Cleared Traditional

K972639 - TINA-QUANT HAPTOGLOBIN

K972639 is an FDA 510(k) clearance for TINA-QUANT HAPTOGLOBIN, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Immunology device with product code DAD cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K972639 · Boehringer Mannheim Corp. · Immunology device
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Jan 1998
Decision
178d
Days
Class 2
Risk

K972639 is an FDA 510(k) clearance for the TINA-QUANT HAPTOGLOBIN. Classified as Haptoglobin, Antigen, Antiserum, Control (product code DAD), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on January 9, 1998 after a review of 178 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5460 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K972639

510(k) Number K972639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1997
Decision Date January 09, 1998
Days to Decision 178 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 104d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DAD Device Classification - Class 2, Special Controls

Product Code DAD Haptoglobin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5460
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 Immunology devices follow this clearance model.

Regulatory Peers - DAD Haptoglobin, Antigen, Antiserum, Control

All 12
Devices cleared under the same product code (DAD) and FDA review panel - the closest regulatory comparables to K972639.
K-ASSAY HAPTOGLOBIN
K993480 · Kamiya Biomedical Co. · Nov 1999
N-ASSAY TIA MULTI V-NL
K964301 · Crestat Diagnostics, Inc. · Jul 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT
K963286 · Beckman Instruments, Inc. · Oct 1996
N/T PROTEIN CONTROL SY/L, M AND H
K952593 · Behring Diagnostics, Inc. · Jul 1995
IL TEST(TM) HAPTOGLOBIN (HPT)
K915829 · Instrumentation Laboratory CO · Jul 1992
RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT
K911898 · Reagents Applications, Inc. · May 1991