Cleared Traditional

K965110 - N-ASSAY TIA MULTI CRP CALIBRATOR SET

K965110 is an FDA 510(k) clearance for N-ASSAY TIA MULTI CRP CALIBRATOR SET, manufactured by Crestat Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K965110 · Crestat Diagnostics, Inc. · Immunology device
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Jul 1997
Decision
195d
Days
Class 2
Risk

K965110 is an FDA 510(k) clearance for the N-ASSAY TIA MULTI CRP CALIBRATOR SET. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Crestat Diagnostics, Inc. (Weston, US). The FDA issued a Cleared decision on July 3, 1997 after a review of 195 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - 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 - K965110

510(k) Number K965110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1996
Decision Date July 03, 1997
Days to Decision 195 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
90d slower than avg
Panel avg: 105d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCK Device Classification - Class 2, Special Controls

Product Code DCK C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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 - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 105
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K965110.
UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE
K973692 · United Biotech, Inc. · Feb 1998
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT
K974050 · Beckman Instruments, Inc. · Nov 1997
CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST
K972160 · Trinity Laboratories, Inc. · Aug 1997
C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT
K962049 · Polymedco, Inc. · Dec 1996
C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST
K962019 · Teco Diagnostics · Nov 1996
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
K963061 · Beckman Instruments, Inc. · Nov 1996