Cleared Traditional

K983860 - MTM BIOSCANNER K TEST STRIPS

K983860 is an FDA 510(k) clearance for MTM BIOSCANNER K TEST STRIPS, manufactured by Polymer Technology Systems, Inc.. The device is a Class 1 Chemistry device with product code JMK cleared through the Traditional 510(k) pathway after a 420-day FDA review.

K983860 · Polymer Technology Systems, Inc. · Chemistry device
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Dec 1999
Decision
420d
Days
Class 1
Risk

K983860 is an FDA 510(k) clearance for the MTM BIOSCANNER K TEST STRIPS, CAT # BSA610. Classified as Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase (product code JMK), Class I - General Controls.

Submitted by Polymer Technology Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on December 27, 1999 after a review of 420 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1380 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Polymer Technology Systems, Inc. devices

FDA 510(k) Submission Details - K983860

510(k) Number K983860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1998
Decision Date December 27, 1999
Days to Decision 420 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
332d slower than avg
Panel avg: 88d · This submission: 420d
Pathway characteristics
Predicate-based equivalence.

JMK Device Classification - Class 1, General Controls

Product Code JMK Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1380
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JMK Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase

All 13
Devices cleared under the same product code (JMK) and FDA review panel - the closest regulatory comparables to K983860.
MTM BIOSCANNER K TEST STRIPS
K981865 · Polymer Technology Systems, Inc. · Feb 1999
SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)
K941427 · Teco Diagnostics · Mar 1995
HBDH (OPTIMIZED) REAGENT
K862319 · Sigma Chemical Co. · Jul 1986
RAICHEM X-HBDH REAGENT
K843774 · Reagents Applications, Inc. · Oct 1984
AHBD
K822739 · Gilford Diagnostics · Oct 1982
HBDH ENZYME KINETIC REAGENT SET
K781720 · Medical Analysis Systems, Inc. · Nov 1978