Cleared Traditional

K772247 - COMPLEMENT C4 NEPHELOMETRIC ASSAY

K772247 is an FDA 510(k) clearance for COMPLEMENT C4 NEPHELOMETRIC ASSAY, manufactured by Kallestad Laboratories, Inc.. The device is a Class 2 Immunology device with product code DBI cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K772247 · Kallestad Laboratories, Inc. · Immunology device
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Dec 1977
Decision
13d
Days
Class 2
Risk

K772247 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 Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1977 after a review of 13 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 Kallestad Laboratories, Inc. devices

FDA 510(k) Submission Details - K772247

510(k) Number K772247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1977
Decision Date December 22, 1977
Days to Decision 13 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
92d faster than avg
Panel avg: 105d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBI Device Classification - Class 2, Special Controls

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 27
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K772247.
FIAX COMPLEMENT C4 TEST KIT
K830669 · Intl. Diagnostic Technology · Apr 1983
IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4
K812490 · Dako Corp. · Sep 1981
COMPLEMENT C4 NEPHELOMETRIC ASSAY
K801361 · J.T. Baker Chemical Co. · Jun 1980
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