Cleared Traditional

K915829 - IL TEST(TM) HAPTOGLOBIN (HPT)

K915829 is the FDA 510(k) clearance for IL TEST(TM) HAPTOGLOBIN (HPT) by Instrumentation Laboratory CO. It is a Class 2 Immunology device (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

Submission Details

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
108d slower than avg
Panel avg: 104d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 9
Devices cleared under the same product code (DAD) and FDA review panel - the closest regulatory comparables to K915829.
TINA-QUANT HAPTOGLOBIN
K972639 · Boehringer Mannheim Corp. · Jan 1998
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
HAPTOGLOBIN
K873866 · Unipath , Ltd. · Oct 1987
QM300 HAPTOGLOBIN ANTIBODY PACK
K872717 · Kallestad Diag, A Div. of Erbamont, Inc. · Jul 1987