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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 89d · 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 Consultant

Tuv Rheinland of North America, Inc.
HEINZ JOERG STENEBERG

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 240
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K030815 · AKERS LABORATORIES INC. BLOOD CELL SEPARATOR
Download PDF FDA Summary Akers Laboratories, I…