Cleared Traditional

K781025 - LAMBDA SERUM (FREE) ANTI-HUMAN

K781025 is the FDA 510(k) clearance for LAMBDA SERUM (FREE) ANTI-HUMAN by Icl Scientific. It is a Class 2 Immunology device (product code DEH) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K781025 · Icl Scientific · Immunology device
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Jul 1978
Decision
38d
Days
Class 2
Risk

K781025 is an FDA 510(k) clearance for the LAMBDA SERUM (FREE) ANTI-HUMAN. Classified as Lambda, Antigen, Antiserum, Control (product code DEH), Class II - Special Controls.

Submitted by Icl Scientific (Mchenry, US). The FDA issued a Cleared decision on July 27, 1978 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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 Icl Scientific devices

Submission Details

510(k) Number K781025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1978
Decision Date July 27, 1978
Days to Decision 38 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
66d faster than avg
Panel avg: 104d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEH Lambda, 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 Immunology devices follow this clearance model.

Regulatory Peers - DEH Lambda, Antigen, Antiserum, Control

All 43
Devices cleared under the same product code (DEH) and FDA review panel - the closest regulatory comparables to K781025.
AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN
K842328 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1984
QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT
K841864 · Kallestad Laboratories, Inc. · Jul 1984
IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA
K812662 · Dako Corp. · Sep 1981
ANTI-HUMAN LAMBDA SERUM
K781220 · Icl Scientific · Jul 1978
GOAT LAMBDA-LIGHT CHAIN ANTI-HUMAN SERUM
K771768 · G.D. Searle and Co. · Oct 1977