Cleared Traditional

K890423 - V-TREND TARGET CRP TEST

K890423 is an FDA 510(k) clearance for V-TREND TARGET CRP TEST, manufactured by Texas Immunology, Inc.. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K890423 · Texas Immunology, Inc. · Immunology device
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Feb 1989
Decision
22d
Days
Class 2
Risk

K890423 is an FDA 510(k) clearance for the V-TREND TARGET CRP TEST. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Texas Immunology, Inc. (Tyler, US). The FDA issued a Cleared decision on February 17, 1989 after a review of 22 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Texas Immunology, Inc. devices

FDA 510(k) Submission Details - K890423

510(k) Number K890423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1989
Decision Date February 17, 1989
Days to Decision 22 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 105d · This submission: 22d
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 K890423.
WAKO(TM) AUTOKIT CRP
K895598 · Wako Chemicals USA, Inc. · Sep 1989
TECHNICON DPA-1 (TM) CRP METHOD
K892198 · Technicon Instruments Corp. · May 1989
SPQ TM TEST SYSTEM II FOR CRP
K892526 · Atlantic Antibodies · May 1989
DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR
K884101 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1988
KALLESTAD QM300 CALIBRATOR C PACK
K880729 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1988
KALLESTAD QM2/QM300 CONTROL C PACK
K880730 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1988