Cleared Traditional

K933972 - N-ASSAY TIA IGG

K933972 is the FDA 510(k) clearance for N-ASSAY TIA IGG by Crestat Diagnostics, Inc.. It is a Class 2 Immunology device (product code CFF) cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K933972 · Crestat Diagnostics, Inc. · Immunology device
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Mar 1994
Decision
221d
Days
Class 2
Risk

K933972 is an FDA 510(k) clearance for the N-ASSAY TIA IGG. Classified as Immunoelectrophoretic, Immunoglobulins, (g, A, M) (product code CFF), Class II - Special Controls.

Submitted by Crestat Diagnostics, Inc. (Thousand Oaks, US). The FDA issued a Cleared decision on March 22, 1994 after a review of 221 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Crestat Diagnostics, Inc. devices

Submission Details

510(k) Number K933972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1993
Decision Date March 22, 1994
Days to Decision 221 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 104d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFF Immunoelectrophoretic, 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 - CFF Immunoelectrophoretic, Immunoglobulins, (g, A, M)

All 17
Devices cleared under the same product code (CFF) and FDA review panel - the closest regulatory comparables to K933972.
K-ASSAY IGA
K993213 · Kamiya Biomedical Co. · Nov 1999
POLYSLIT IFE KIT
K990998 · Helena Laboratories · Jun 1999
SPIFE IFE-6
K973040 · Helena Laboratories · Jan 1998
IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC
K924767 · The Binding Site, Ltd. · Feb 1993
IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC
K924769 · The Binding Site, Ltd. · Feb 1993
REP IMMUNOFIX
K923658 · Helena Laboratories · Nov 1992