Cleared Traditional

K030687 - K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090

Also marketed or referenced as:
KAJ-091C

K030687 is an FDA 510(k) clearance for K-ASSAY D-DIMER, 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 114-day FDA review.

K030687 · Kamiya Biomedical Co. · Hematology device
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Jun 2003
Decision
114d
Days
Class 2
Risk

K030687 is an FDA 510(k) clearance for the K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090. 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 June 27, 2003 after a review of 114 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 Kamiya Biomedical Co. devices

FDA 510(k) Submission Details - K030687

510(k) Number K030687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2003
Decision Date June 27, 2003
Days to Decision 114 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
1d slower than avg
Panel avg: 113d · This submission: 114d
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 K030687.
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K030328 · bioMerieux, Inc. · Sep 2003
STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
K022976 · Dade Behring, Inc. · Jan 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