Cleared Traditional

K193649 - Yumizen C1200 Creatinine PAP

K193649 is an FDA 510(k) clearance for Yumizen C1200 Creatinine PAP, manufactured by HORIBA ABX SAS. The device is a Class 2 Chemistry device with product code JFY cleared through the Traditional 510(k) pathway after a 497-day FDA review.

K193649 · HORIBA ABX SAS · Chemistry device
Download Printable Device Report (PDF)
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May 2021
Decision
497d
Days
Class 2
Risk

K193649 is an FDA 510(k) clearance for the Yumizen C1200 Creatinine PAP. Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by HORIBA ABX SAS (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on May 10, 2021 after a review of 497 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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 HORIBA ABX SAS devices

FDA 510(k) Submission Details - K193649

510(k) Number K193649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2019
Decision Date May 10, 2021
Days to Decision 497 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
409d slower than avg
Panel avg: 88d · This submission: 497d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFY Device Classification - Class 2, Special Controls

Product Code JFY Enzymatic Method, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - JFY Enzymatic Method, Creatinine

All 33
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K193649.
QSCHECK UISACR
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