Cleared Traditional

K964294 - N-ASSAY TIA APO A1/B MULTI CALIBRATOR

K964294 is an FDA 510(k) clearance for N-ASSAY TIA APO A1/B MULTI CALIBRATOR, manufactured by Crestat Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DER cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K964294 · Crestat Diagnostics, Inc. · Immunology device
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Aug 1997
Decision
276d
Days
Class 2
Risk

K964294 is an FDA 510(k) clearance for the N-ASSAY TIA APO A1/B MULTI CALIBRATOR. Classified as Alpha-1-lipoprotein, Antigen, Antiserum, Control (product code DER), Class II - Special Controls.

Submitted by Crestat Diagnostics, Inc. (Murrieta, US). The FDA issued a Cleared decision on August 1, 1997 after a review of 276 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5580 - 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 - K964294

510(k) Number K964294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1996
Decision Date August 01, 1997
Days to Decision 276 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
171d slower than avg
Panel avg: 105d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DER Device Classification - Class 2, Special Controls

Product Code DER Alpha-1-lipoprotein, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5580
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 - DER Alpha-1-lipoprotein, Antigen, Antiserum, Control

All 11
Devices cleared under the same product code (DER) and FDA review panel - the closest regulatory comparables to K964294.
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
K990594 · Roche Diagnostics Corp. · Apr 1999
APOLIPOPROTEIN A1
K983289 · Abbott Laboratories · Jan 1999
N-ASSAY TIA APO A1 TEST KIT
K964292 · Crestat Diagnostics, Inc. · Aug 1997
N-ASSAY TIA APO B TEST KIT
K964296 · Crestat Diagnostics, Inc. · Aug 1997
ROCHE APOLIPOPROTEIN STANDARD
K910553 · Roche Diagnostic Systems, Inc. · May 1991
VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN
K840830 · Ventrex Laboratories, Inc. · May 1984