Cleared Traditional

K871896 - TINA-QUANT [A] TRANSFERRIN

K871896 is an FDA 510(k) clearance for TINA-QUANT [A] TRANSFERRIN, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Immunology device with product code DDG cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K871896 · Boehringer Mannheim Corp. · Immunology device
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Jun 1987
Decision
31d
Days
Class 2
Risk

K871896 is an FDA 510(k) clearance for the TINA-QUANT [A] TRANSFERRIN. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on June 15, 1987 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5880 - 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: 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K871896

510(k) Number K871896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1987
Decision Date June 15, 1987
Days to Decision 31 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 104d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDG Device Classification - Class 2, Special Controls

Product Code DDG Transferrin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5880
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 - DDG Transferrin, Antigen, Antiserum, Control

All 40
Devices cleared under the same product code (DDG) and FDA review panel - the closest regulatory comparables to K871896.
IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN
K884075 · Orion Diagnostica, Inc. · Oct 1988
TRANSFERRIN
K873867 · Unipath , Ltd. · Oct 1987
QM300 TRANSFERRIN ANTIBODY PACK
K873789 · Kallestad Diag, A Div. of Erbamont, Inc. · Oct 1987
PRECIMAT(R) TRANSFERRIN
K871022 · Boehringer Mannheim Corp. · May 1987
TDX TRANSFERRIN DIAGNOSTIC KIT
K854416 · Abbott Laboratories · Feb 1986
IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN
K812492 · Dako Corp. · Sep 1981