Cleared Traditional

K083729 - HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN

K083729 is an FDA 510(k) clearance for HEMOCLOT QUANTI- V-L, manufactured by Aniara Diagnostica, LLC. The device is a Class 2 Hematology device with product code GGW cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K083729 · Aniara Diagnostica, LLC · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
143d
Days
Class 2
Risk

K083729 is an FDA 510(k) clearance for the HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIO.... Classified as Test, Time, Partial Thromboplastin (product code GGW), Class II - Special Controls.

Submitted by Aniara Diagnostica, LLC (Mason, US). The FDA issued a Cleared decision on May 8, 2009 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - 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 Aniara Diagnostica, LLC devices

FDA 510(k) Submission Details - K083729

510(k) Number K083729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2008
Decision Date May 08, 2009
Days to Decision 143 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 113d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGW Device Classification - Class 2, Special Controls

Product Code GGW Test, Time, Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 - GGW Test, Time, Partial Thromboplastin

All 28
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