Cleared Traditional

Pointe Scientific Creatinine Kinase (CK) Reagent Set (K191296) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191296 · Medtest DX · Chemistry device
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Aug 2020
Decision
455d
Days
Class 2
Risk

K191296 is an FDA 510(k) clearance for the Pointe Scientific Creatinine Kinase (CK) Reagent Set. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Medtest DX (Lincoln Park, US). The FDA issued a Cleared decision on August 11, 2020 after a review of 455 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - 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.

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Submission Details

510(k) Number K191296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2019
Decision Date August 11, 2020
Days to Decision 455 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
367d slower than avg
Panel avg: 88d · This submission: 455d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGS Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
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 - CGS Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes

All 122
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K191296.
SEKURE Creatine Kinase Assay
K182702 · Sekisui Diagnostics P.E.I., Inc. · Apr 2019
CK
K983070 · Abbott Laboratories · Feb 1999
CREATINE KINASE (CK)
K981218 · Abbott Laboratories · May 1998
ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC
K890540 · Abbott Laboratories · Feb 1989
VISION CREATINE KINASE
K883946 · Abbott Laboratories · Oct 1988
CPK-L TUBE
K781149 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1978