Cleared Traditional

K760917 - LAS-R HUMAN HAPTOGLOBIN TEST

K760917 is an FDA 510(k) clearance for LAS-R HUMAN HAPTOGLOBIN TEST, manufactured by Hyland Therapeutic Div., Travenol Laboratories. The device is a Class 2 Pathology device with product code DFT cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K760917 · Hyland Therapeutic Div., Travenol Laboratories · Pathology device
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Dec 1976
Decision
63d
Days
Class 2
Risk

K760917 is an FDA 510(k) clearance for the LAS-R HUMAN HAPTOGLOBIN TEST. Classified as Igm, Antigen, Antiserum, Control (product code DFT), Class II - Special Controls.

Submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on December 30, 1976 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.5550 - the FDA pathology 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.

FDA 510(k) Submission Details - K760917

510(k) Number K760917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1976
Decision Date December 30, 1976
Days to Decision 63 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 78d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFT Device Classification - Class 2, Special Controls

Product Code DFT Igm, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 Pathology devices follow this clearance model.

Regulatory Peers - DFT Igm, Antigen, Antiserum, Control

All 32
Devices cleared under the same product code (DFT) and FDA review panel - the closest regulatory comparables to K760917.
LANCER L-INA ANTI-IGM
K791402 · Sherwood Medical Co. · Oct 1979
IMMUNOGLOBULIN M NEPHEL. ASSAY
K772254 · Kallestad Laboratories, Inc. · Dec 1977
GOAT ANTISERUM IGM NEPHELOMHTRIC
K770963 · Kallestad Laboratories, Inc. · Jun 1977
RAPI/TEX-LGM KIT
K760673 · Hoechst-Roussel Pharmaceuticals, Inc. · Dec 1976
SERUM, IGM ANTI-HUMAN ACID
K760147 · Oxford Laboratories, Inc. · Jul 1976
K760917 · LAS-R HUMAN HAPTOGLOBIN TEST
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