Cleared Traditional

K002948 - K-ASSAY D-DIMER WITH CALIBRATOR SET AND...

K002948 is the FDA 510(k) clearance for K-ASSAY D-DIMER WITH CALIBRATOR SET AND... by Kamiya Biomedical Co.. It is a Class 2 Hematology device (product code DAP) cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K002948 · Kamiya Biomedical Co. · Hematology device
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May 2001
Decision
239d
Days
Class 2
Risk

K002948 is an FDA 510(k) clearance for the K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT. Classified as Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (product code DAP), Class II - Special Controls.

Submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on May 18, 2001 after a review of 239 days - an extended review cycle.

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 Kamiya Biomedical Co. devices

Submission Details

510(k) Number K002948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2000
Decision Date May 18, 2001
Days to Decision 239 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 113d · This submission: 239d
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 43
Devices cleared under the same product code (DAP) and FDA review panel - the closest regulatory comparables to K002948.
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
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K013544 · Sigma Diagnostics, Inc. · Nov 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
K013545 · Sigma Diagnostics, Inc. · Nov 2001
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA
K002706 · Roche Diagnostics Corp. · Mar 2001
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
K003267 · Sigma Diagnostics, Inc. · Mar 2001
MDA D-DIMER
K000492 · Organon Teknika Corp. · Jun 2000