Cleared Traditional

K182063 - VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System

K182063 is an FDA 510(k) clearance for VITROS Chemistry Products CRBM Slides, manufactured by Ortho-Clinical Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JFY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K182063 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
90d
Days
Class 2
Risk

K182063 is an FDA 510(k) clearance for the VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides,.... Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on October 30, 2018 after a review of 90 days - within the typical 510(k) review window.

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: 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.

View all Ortho-Clinical Diagnostics, Inc. devices

FDA 510(k) Submission Details - K182063

510(k) Number K182063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2018
Decision Date October 30, 2018
Days to Decision 90 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
2d slower than avg
Panel avg: 88d · This submission: 90d
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 K182063.
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