Cleared Traditional

K801361 - COMPLEMENT C4 NEPHELOMETRIC ASSAY

K801361 is the FDA 510(k) clearance for COMPLEMENT C4 NEPHELOMETRIC ASSAY by J.T. Baker Chemical Co.. It is a Class 2 Immunology device (product code DBI) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K801361 · J.T. Baker Chemical Co. · Immunology device
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Jun 1980
Decision
21d
Days
Class 2
Risk

K801361 is an FDA 510(k) clearance for the COMPLEMENT C4 NEPHELOMETRIC ASSAY. Classified as Complement C4, Antigen, Antiserum, Control (product code DBI), Class II - Special Controls.

Submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1980 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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 J.T. Baker Chemical Co. devices

Submission Details

510(k) Number K801361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1980
Decision Date June 30, 1980
Days to Decision 21 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
83d faster than avg
Panel avg: 104d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBI Complement C4, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - DBI Complement C4, Antigen, Antiserum, Control

All 23
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K801361.
C4 ANTIGEN ANTIBODY CONTROL
K834605 · Technicon Instruments Corp. · Jan 1984
RABBIT ANTISERUM TO HUMAN C4
K831906 · Dako Corp. · Jul 1983
IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4
K812490 · Dako Corp. · Sep 1981
COMPLEMENT C4 NEPHELOMETRIC ASSAY
K772247 · Kallestad Laboratories, Inc. · Dec 1977
HUMAN C4 COMPLEMENT CONTROL SERUM
K772004 · G.D. Searle and Co. · Nov 1977
PLATES FOR HUMAN C4 COMPLEMENT
K772002 · G.D. Searle and Co. · Nov 1977