Cleared Traditional

K183555 - GEM Premier ChemSTAT

K183555 is an FDA 510(k) clearance for GEM Premier ChemSTAT, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Chemistry device with product code JFY cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K183555 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
58d
Days
Class 2
Risk

K183555 is an FDA 510(k) clearance for the GEM Premier ChemSTAT. Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on February 16, 2019 after a review of 58 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K183555

510(k) Number K183555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2018
Decision Date February 16, 2019
Days to Decision 58 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
30d faster than avg
Panel avg: 88d · This submission: 58d
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 41
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K183555.
Atellica CH Enzymatic Creatinine_3 (ECre3)
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Yumizen C1200 Creatinine PAP
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ACR LAB Urine Analysis Test System
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URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
K182038 · Yd Diagnostics Corporation · Dec 2018
VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System
K182063 · Ortho-Clinical Diagnostics, Inc. · Oct 2018
Teco Creatinine Enzymatic Reagent Kit
K161527 · Teco Diagnostics, Inc. · Jul 2017