Cleared Traditional

K873866 - HAPTOGLOBIN

K873866 is an FDA 510(k) clearance for HAPTOGLOBIN, manufactured by Unipath , Ltd.. The device is a Class 2 Immunology device with product code DAD cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K873866 · Unipath , Ltd. · Immunology device
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Oct 1987
Decision
57d
Days
Class 2
Risk

K873866 is an FDA 510(k) clearance for the HAPTOGLOBIN. Classified as Haptoglobin, Antigen, Antiserum, Control (product code DAD), Class II - Special Controls.

Submitted by Unipath , Ltd. (Bedford Mk41 Oqg, GB). The FDA issued a Cleared decision on October 20, 1987 after a review of 57 days - a notably fast clearance 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: 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 Unipath , Ltd. devices

FDA 510(k) Submission Details - K873866

510(k) Number K873866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1987
Decision Date October 20, 1987
Days to Decision 57 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
48d faster than avg
Panel avg: 105d · This submission: 57d
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 14
Devices cleared under the same product code (DAD) and FDA review panel - the closest regulatory comparables to K873866.
IL TEST(TM) HAPTOGLOBIN (HPT)
K915829 · Instrumentation Laboratory CO · Jul 1992
RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT
K911898 · Reagents Applications, Inc. · May 1991
SPQ(TM) ANTIBODY REAGENT SET II FOR HPT
K890562 · Atlantic Antibodies · Feb 1989
QM300 HAPTOGLOBIN ANTIBODY PACK
K872717 · Kallestad Diag, A Div. of Erbamont, Inc. · Jul 1987
IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO
K864512 · Cooper Biomedical, Inc. · Feb 1987
DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB
K831957 · Kent Laboratories, Inc. · Jul 1983