Cleared Traditional

K964698 - SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT

K964698 is an FDA 510(k) clearance for SAFETEX COMBINATION BLOOD (ALCOHOL, manufactured by Andwin Scientific. The device is a Class 2 General Hospital device with product code JKA cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K964698 · Andwin Scientific · General Hospital
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Mar 1997
Decision
101d
Days
Class 2
Risk

K964698 is an FDA 510(k) clearance for the SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Andwin Scientific (Draper, US). The FDA issued a Cleared decision on March 3, 1997 after a review of 101 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 862.1675 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Andwin Scientific devices

FDA 510(k) Submission Details - K964698

510(k) Number K964698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1996
Decision Date March 03, 1997
Days to Decision 101 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 129d · This submission: 101d
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 General Hospital devices follow this clearance model.

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

All 143
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K964698.
GREINER VACUETTE BLOOD COLLECTION TUBE
K971220 · Greiner America, Inc. · Jun 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971236 · Greiner America, Inc. · May 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971239 · Greiner America, Inc. · May 1997
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET
K965202 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1997
PICO MODELS 30, 50, 70
K962158 · Radiometer America, Inc. · Oct 1996
SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT
K962931 · Smiths Industries Medical Systems, Inc. · Oct 1996