Cleared Traditional

K914155 - TIA CRP TEST KIT

K914155 is an FDA 510(k) clearance for TIA CRP TEST KIT, 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 121-day FDA review.

K914155 · Crestat Diagnostics, Inc. · Immunology device
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Jan 1992
Decision
121d
Days
Class 2
Risk

K914155 is an FDA 510(k) clearance for the TIA CRP TEST KIT. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Crestat Diagnostics, Inc. (Torrance, US). The FDA issued a Cleared decision on January 15, 1992 after a review of 121 days - within the typical 510(k) review window.

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 - K914155

510(k) Number K914155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1991
Decision Date January 15, 1992
Days to Decision 121 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
16d slower than avg
Panel avg: 105d · This submission: 121d
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 K914155.
TINA-QUANT CRP
K930621 · Boehringer Mannheim Corp. · Mar 1993
VIGIL II
K920845 · Beckman Instruments, Inc. · Dec 1992
ACCUTEX CRP LATEX TEST
K924332 · J.S. Medical Assoc. · Dec 1992
HUMAN C-REACTIVE PROTEIN RID KIT
K905633 · The Binding Site, Ltd. · Jul 1991
WAKO(TM) AUTOKIT CRP
K895598 · Wako Chemicals USA, Inc. · Sep 1989
TECHNICON DPA-1 (TM) CRP METHOD
K892198 · Technicon Instruments Corp. · May 1989