Cleared Traditional

K003267 - SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A

K003267 is an FDA 510(k) clearance for SIGMA DIAGNOSTICS AUTO D-DIMER, manufactured by Sigma Diagnostics, Inc.. The device is a Class 2 Hematology device with product code DAP cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K003267 · Sigma Diagnostics, Inc. · Hematology device
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Mar 2001
Decision
148d
Days
Class 2
Risk

K003267 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A. Classified as Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (product code DAP), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 15, 2001 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7320 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sigma Diagnostics, Inc. devices

FDA 510(k) Submission Details - K003267

510(k) Number K003267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2000
Decision Date March 15, 2001
Days to Decision 148 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 113d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DAP Device Classification - Class 2, Special Controls

Product Code DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7320
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 Hematology devices follow this clearance model.

Regulatory Peers - DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

All 50
Devices cleared under the same product code (DAP) and FDA review panel - the closest regulatory comparables to K003267.
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
K013545 · Sigma Diagnostics, Inc. · Nov 2001
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
K002948 · Kamiya Biomedical Co. · May 2001
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA
K002706 · Roche Diagnostics Corp. · Mar 2001
MDA D-DIMER
K000492 · Organon Teknika Corp. · Jun 2000
ADVANCED D-DIMER
K992957 · Dade Behring, Inc. · Jan 2000
DIMERTEST LATEX ASSAY
K974596 · Agen Biomedical , Ltd. · May 1998