Cleared Traditional

K965100 - N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT

K965100 is the FDA 510(k) clearance for N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT by Crestat Diagnostics, Inc.. It is a Class 2 Immunology device (product code DEM) cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K965100 · Crestat Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
206d
Days
Class 2
Risk

K965100 is an FDA 510(k) clearance for the N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT. Classified as Alpha-1-antitrypsin, Antigen, Antiserum, Control (product code DEM), Class II - Special Controls.

Submitted by Crestat Diagnostics, Inc. (Weston, US). The FDA issued a Cleared decision on July 14, 1997 after a review of 206 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5130 - 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 K965100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1996
Decision Date July 14, 1997
Days to Decision 206 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
102d slower than avg
Panel avg: 104d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEM Alpha-1-antitrypsin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5130
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 - DEM Alpha-1-antitrypsin, Antigen, Antiserum, Control

All 21
Devices cleared under the same product code (DEM) and FDA review panel - the closest regulatory comparables to K965100.
CHEMMATE L26 (CD20)
K973390 · Ventana Medical Systems, Inc. · Oct 1997
CHEMMATE KAPPA
K973391 · Ventana Medical Systems, Inc. · Oct 1997
CHEMMATE LAMBDA
K973392 · Ventana Medical Systems, Inc. · Oct 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)
K964766 · Beckman Instruments, Inc. · Apr 1997
VENTANA NEGATIVE CONTROL REAGENT
K931979 · Ventana Medical Systems, Inc. · Mar 1994
IL TEST ALPHA-1-ANTITRYPSIN (AAT)
K920005 · Instrumentation Laboratory CO · Jul 1992