Cleared Traditional

K772114 - FIAX C4 ASSAY

K772114 is the FDA 510(k) clearance for FIAX C4 ASSAY by Idt, A Division of Whittaker M.A. Bioproducts. It is a Class 2 Immunology device (product code DAK) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K772114 · Idt, A Division of Whittaker M.A. Bioproducts · Immunology device
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Nov 1977
Decision
23d
Days
Class 2
Risk

K772114 is an FDA 510(k) clearance for the FIAX C4 ASSAY. Classified as Complement C1q, Antigen, Antiserum, Control (product code DAK), Class II - Special Controls.

Submitted by Idt, A Division of Whittaker M.A. Bioproducts (Mchenry, US). The FDA issued a Cleared decision on November 30, 1977 after a review of 23 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 Idt, A Division of Whittaker M.A. Bioproducts devices

Submission Details

510(k) Number K772114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1977
Decision Date November 30, 1977
Days to Decision 23 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 104d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DAK Complement C1q, 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 - DAK Complement C1q, Antigen, Antiserum, Control

All 14
Devices cleared under the same product code (DAK) and FDA review panel - the closest regulatory comparables to K772114.
ELECTRO-IMMUNO-QUANTITATION (EIQ)
K792472 · Icl Scientific · Dec 1979
ANTI-HUMAN CIQ SERUM
K781022 · Icl Scientific · Aug 1978
LAS-R HUMAN COMPLEMENT CLQ TEST
K780729 · Hyland Therapeutic Div., Travenol Laboratories · May 1978
HUMAN REFERENCE SERUM C4 COMPLEMENT
K772003 · G.D. Searle and Co. · Nov 1977
GOAT ANTISERUM COMPLEMENT C3 NEPHEL.
K770964 · Kallestad Laboratories, Inc. · Jun 1977
LAS-R TM HUMAN COMPLEMENT C4 TEST
K770547 · Hyland Therapeutic Div., Travenol Laboratories · May 1977