Cleared Traditional

K915829 - IL TEST(TM) HAPTOGLOBIN (HPT)

K915829 is an FDA 510(k) clearance for IL TEST(TM) HAPTOGLOBIN (HPT), manufactured by Instrumentation Laboratory CO. The device is a Class 2 Immunology device with product code DAD cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K915829 · Instrumentation Laboratory CO · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
212d
Days
Class 2
Risk

K915829 is an FDA 510(k) clearance for the IL TEST(TM) HAPTOGLOBIN (HPT). Classified as Haptoglobin, Antigen, Antiserum, Control (product code DAD), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on July 29, 1992 after a review of 212 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 Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K915829

510(k) Number K915829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1991
Decision Date July 29, 1992
Days to Decision 212 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
107d slower than avg
Panel avg: 105d · This submission: 212d
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 K915829.
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
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
HAPTOGLOBIN
K873866 · Unipath , Ltd. · Oct 1987