Cleared Traditional

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

K002948 is an FDA 510(k) clearance for K-ASSAY D-DIMER WITH CALIBRATOR SET AND..., manufactured by Kamiya Biomedical Co.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K002948

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.

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 48
Devices cleared under the same product code (DAP) and FDA review panel - the closest regulatory comparables to K002948.
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K003267 · Sigma Diagnostics, Inc. · Mar 2001
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K000492 · Organon Teknika Corp. · Jun 2000