Cleared Traditional

K893613 - STATSPIN MINI-PLASMA

K893613 is an FDA 510(k) clearance for STATSPIN MINI-PLASMA, manufactured by Statspin Technologies. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K893613 · Statspin Technologies · Chemistry device
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Aug 1989
Decision
110d
Days
Class 2
Risk

K893613 is an FDA 510(k) clearance for the STATSPIN MINI-PLASMA. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Statspin Technologies (Norwood, US). The FDA issued a Cleared decision on August 28, 1989 after a review of 110 days - within the typical 510(k) review window.

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 - K893613

510(k) Number K893613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1989
Decision Date August 28, 1989
Days to Decision 110 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 89d · This submission: 110d
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 240
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K893613.
STATSPIN STATSAMPLER
K896206 · Statspin Technologies · Nov 1989
PRO-JECT(TM) SAFETY NEEDLE HOLDER
K892665 · Pro-Tec Containers, Inc. · Oct 1989
PINSET
K884970 · Safety Diagnostics, Inc. · Sep 1989
SAFEPETTE DISPENSER
K890109 · Safe-Tec Clinical Products, Inc. · Feb 1989
LIPOCLEAR LIPEMIA CLEARING REAGENT
K884807 · Statspin Technologies · Jan 1989
PUMPETTE(TM)
K884111 · Helena Laboratories · Dec 1988
K893613 · STATSPIN MINI-PLASMA
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