Cleared Traditional

K933970 - N-ASSAY TIA IGM

K933970 is an FDA 510(k) clearance for N-ASSAY TIA IGM, manufactured by Crestat Diagnostics, Inc.. The device is a Class 2 Immunology device with product code CFN cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K933970 · Crestat Diagnostics, Inc. · Immunology device
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Mar 1994
Decision
221d
Days
Class 2
Risk

K933970 is an FDA 510(k) clearance for the N-ASSAY TIA IGM. Classified as Method, Nephelometric, Immunoglobulins (g, A, M) (product code CFN), 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

FDA 510(k) Submission Details - K933970

510(k) Number K933970 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 105d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFN Device Classification - Class 2, Special Controls

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 56
Devices cleared under the same product code (CFN) and FDA review panel - the closest regulatory comparables to K933970.
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COBAS INTEGRA REAGENT CASSETTES
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N-ASSAY TIA IGA
K933971 · Crestat Diagnostics, Inc. · Mar 1994
N-ASSAY TIA MULTI V-NL
K933973 · Crestat Diagnostics, Inc. · Jan 1994
WAKO IGG-HA
K923070 · Wako Chemicals USA, Inc. · Aug 1992