Cleared Traditional

K781655 - NEPHELRATE ANTISERUMS 1GA

K781655 is the FDA 510(k) clearance for NEPHELRATE ANTISERUMS 1GA by Antibodies, Inc.. It is a Class 2 Immunology device (product code CFN) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K781655 · Antibodies, Inc. · Immunology device
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Nov 1978
Decision
42d
Days
Class 2
Risk

K781655 is an FDA 510(k) clearance for the NEPHELRATE ANTISERUMS 1GA. Classified as Method, Nephelometric, Immunoglobulins (g, A, M) (product code CFN), Class II - Special Controls.

Submitted by Antibodies, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 8, 1978 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 Antibodies, Inc. devices

Submission Details

510(k) Number K781655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1978
Decision Date November 08, 1978
Days to Decision 42 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 104d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFN Method, Nephelometric, Immunoglobulins (g, A, M)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - CFN Method, Nephelometric, Immunoglobulins (g, A, M)

All 52
Devices cleared under the same product code (CFN) and FDA review panel - the closest regulatory comparables to K781655.
N PROTEIN STANDARD PLASMA (HUMAN)
K880356 · Behring Diagnostics, Inc. · Apr 1988
QM2/QM300 BUFFER AND DILUENT PACK
K871343 · Kallestad Diag, A Div. of Erbamont, Inc. · May 1987
BEHRING NEPHELOMETER SYSTEM
K860894 · Behring Diagnostics, Inc. · Apr 1986
LAS-R TEST PROGRAM
K771226 · Hyland Therapeutic Div., Travenol Laboratories · Jul 1977