Cleared Traditional

K923768 - PULSE CRP TEST

K923768 is an FDA 510(k) clearance for PULSE CRP TEST, manufactured by Pulse Scientific, Inc.. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K923768 · Pulse Scientific, Inc. · Immunology device
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Dec 1992
Decision
126d
Days
Class 2
Risk

K923768 is an FDA 510(k) clearance for the PULSE CRP TEST. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Pulse Scientific, Inc. (Burlington, Ont., Canada, CA). The FDA issued a Cleared decision on December 1, 1992 after a review of 126 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 Pulse Scientific, Inc. devices

FDA 510(k) Submission Details - K923768

510(k) Number K923768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1992
Decision Date December 01, 1992
Days to Decision 126 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
21d slower than avg
Panel avg: 105d · This submission: 126d
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 106
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K923768.
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
TIA CRP TEST KIT
K914155 · Crestat Diagnostics, Inc. · Jan 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