Cleared Traditional

K050231 - ELECSYS CA 19-9 IMMUNOASSAY

K050231 is the FDA 510(k) clearance for ELECSYS CA 19-9 IMMUNOASSAY by Roche Diagnostics Corp.. It is a Class 2 Immunology device (product code JIT) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K050231 · Roche Diagnostics Corp. · Immunology device
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Optimized for regulatory review, auditing and printing
Jul 2005
Decision
161d
Days
Class 2
Risk

K050231 is an FDA 510(k) clearance for the ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 6, 2005 after a review of 161 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K050231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2005
Decision Date July 06, 2005
Days to Decision 161 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 104d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 Immunology devices follow this clearance model.

Regulatory Peers - JIT Calibrator, Secondary

All 137
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K050231.
ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET
K052982 · Roche Diagnostics · Oct 2005
ISE COMPENSATOR
K052193 · Roche Diagnostics · Oct 2005
IRON STANDARD
K052002 · Roche Diagnostics Corp. · Aug 2005
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23
K042838 · Ortho-Clinical Diagnostics, Inc. · Dec 2004
OLYMPUS LACTATE, OSR6193
K042406 · Olympus America, Inc. · Dec 2004
ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
K043095 · Roche Diagnostics Corp. · Nov 2004