Cleared Traditional

K030815 - AKERS LABORATORIES INC. BLOOD CELL SEPARATOR

K030815 is an FDA 510(k) clearance for AKERS LABORATORIES INC. BLOOD CELL SEPA..., manufactured by Akers Laboratories, Inc.. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K030815 · Akers Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
187d
Days
Class 2
Risk

K030815 is an FDA 510(k) clearance for the AKERS LABORATORIES INC. BLOOD CELL SEPARATOR. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Akers Laboratories, Inc. (Thorofare, US). The FDA issued a Cleared decision on September 17, 2003 after a review of 187 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Akers Laboratories, Inc. devices

FDA 510(k) Submission Details - K030815

510(k) Number K030815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2003
Decision Date September 17, 2003
Days to Decision 187 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 88d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

JKA Device Classification - Class 2, Special Controls

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 Chemistry devices follow this clearance model.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 169
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