Cleared Traditional

K965024 - N-ASSAY TIA C1-INACTIVATOR TEST KIT

K965024 is the FDA 510(k) clearance for N-ASSAY TIA C1-INACTIVATOR TEST KIT by Crestat Diagnostics, Inc.. It is a Class 2 Immunology device (product code DBA) cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K965024 · Crestat Diagnostics, Inc. · Immunology device
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Jul 1997
Decision
209d
Days
Class 2
Risk

K965024 is an FDA 510(k) clearance for the N-ASSAY TIA C1-INACTIVATOR TEST KIT. Classified as Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control (product code DBA), 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 209 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5250 - 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 K965024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1996
Decision Date July 14, 1997
Days to Decision 209 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
105d slower than avg
Panel avg: 104d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBA Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5250
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 - DBA Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control

All 11
Devices cleared under the same product code (DBA) and FDA review panel - the closest regulatory comparables to K965024.
DIMENSION VISTA C1 IN
K072965 · Dade Behring, Inc. · Dec 2007
K-ASSAY C1-INA
K011780 · Kamiya Biomedical Co. · Jul 2001
C1-INHIBITOR MICROTITER ASSAY DEVICE
K003747 · Baxter Healthcare Corp · Mar 2001
N ANTISERUM TO C1 INHIBITOR
K960257 · Behring Diagnostics, Inc. · Aug 1996
HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT
K951967 · Kent Laboratories, Inc. · May 1995
COMPLEMENT C1 INACTIVATOR KIT
K915431 · The Binding Site, Ltd. · Jan 1992