Cleared Traditional

K022976 - STRATUS CS D-DIMER (DDMR) METHOD (TESTP...

K022976 is the FDA 510(k) clearance for STRATUS CS D-DIMER (DDMR) METHOD (TESTP... by Dade Behring, Inc.. It is a Class 2 Hematology device (product code DAP) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K022976 · Dade Behring, Inc. · Hematology device
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Jan 2003
Decision
132d
Days
Class 2
Risk

K022976 is an FDA 510(k) clearance for the STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D. Classified as Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (product code DAP), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on January 16, 2003 after a review of 132 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K022976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2002
Decision Date January 16, 2003
Days to Decision 132 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
19d slower than avg
Panel avg: 113d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 41
Devices cleared under the same product code (DAP) and FDA review panel - the closest regulatory comparables to K022976.
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VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
K030328 · bioMerieux, Inc. · Sep 2003
STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C
K022977 · Dade Behring, Inc. · Nov 2002
VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
K020810 · bioMerieux, Inc. · Oct 2002
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
K013549 · Sigma Diagnostics, Inc. · Dec 2001