Cleared Traditional

K965024 - N-ASSAY TIA C1-INACTIVATOR TEST KIT

K965024 is an FDA 510(k) clearance for N-ASSAY TIA C1-INACTIVATOR TEST KIT, manufactured by Crestat Diagnostics, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K965024

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 105d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBA Device Classification - Class 2, Special Controls

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