Cleared Traditional

K030076 - PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM

K030076 is an FDA 510(k) clearance for PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM, manufactured by Biomed Personal Metabolic and Nutritional Testing. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K030076 · Biomed Personal Metabolic and Nutritional Testing · Chemistry device
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Jul 2003
Decision
180d
Days
Class 2
Risk

K030076 is an FDA 510(k) clearance for the PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Biomed Personal Metabolic and Nutritional Testing (Memphis, US). The FDA issued a Cleared decision on July 7, 2003 after a review of 180 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 - K030076

510(k) Number K030076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2003
Decision Date July 07, 2003
Days to Decision 180 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 89d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 236
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K030076.
FLUID SAMPLE RETRIEVAL SYSTEM
K030394 · Biomed Personal Metabolic and Nutritional Testing · Oct 2003
AKERS LABORATORIES INC. BLOOD CELL SEPARATOR
K030815 · Akers Laboratories, Inc. · Sep 2003
IMMUNICON CELLSAVE PRESERVATIVE TUBE
K030596 · Immunicon Corp. · Aug 2003
BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341
K030573 · Bd Vacutainer Systems Preanalyical Solutions · May 2003
VACUETTE TRACE ELEMENTS TUBES
K023971 · Greiner Bio-One Vacuette North America · Jan 2003
BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE
K023075 · Bd Vacutainer Systems Preanalyical Solutions · Nov 2002
K030076 · PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM
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