Cleared Traditional

K122242 - ELECSYS CA 15-3 II CALCHECK 5

K122242 is the FDA 510(k) clearance for ELECSYS CA 15-3 II CALCHECK 5 by Roche Diagnostics. It is a Class 1 Immunology device (product code JJX) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K122242 · Roche Diagnostics · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
131d
Days
Class 1
Risk

K122242 is an FDA 510(k) clearance for the ELECSYS CA 15-3 II CALCHECK 5. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on December 5, 2012 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - 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 devices

Submission Details

510(k) Number K122242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2012
Decision Date December 05, 2012
Days to Decision 131 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
27d slower than avg
Panel avg: 104d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 268
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K122242.
HBA1C CONTROL, LEVEL 1 AND LEVEL 2
K131999 · Randox Laboratories, Ltd. · Jul 2013
ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3
K131776 · Randox Laboratories, Ltd. · Jul 2013
IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL
K122534 · Siemens Healthcare Diagnostics, Inc. · Mar 2013
ELECSYS HSV-2 IGG IMMUNOASSAY
K121895 · Roche Diagnostics · Aug 2012
RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)
K121746 · Randox Laboratories, Ltd. · Jul 2012
RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3
K121588 · Randox Laboratories, Ltd. · Jun 2012