Cleared Traditional

K092848 - ELECSYS TROPONIN T CALCHECK 5

K092848 is the FDA 510(k) clearance for ELECSYS TROPONIN T CALCHECK 5 by Roche Diagnostics Corp.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K092848 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
184d
Days
Class 1
Risk

K092848 is an FDA 510(k) clearance for the ELECSYS TROPONIN T CALCHECK 5. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 19, 2010 after a review of 184 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K092848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2009
Decision Date March 19, 2010
Days to Decision 184 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 88d · This submission: 184d
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 K092848.
ELECSYS TSH CALCHECK 5
K093836 · Roche Diagnostics · Apr 2010
ELECSYS TROPONIN I CALCHECK 5
K100594 · Roche Diagnostics · Apr 2010
ELECSYS CK-MB CALCHECK 5
K093582 · Roche Diagnostics · Mar 2010
ELECSYS HCG STAT CALCHECK 5
K093700 · Roche Diagnostics Corp. · Mar 2010
ELECSYS PROBNP II CALCHECK 5
K092169 · Roche Diagnostics · Dec 2009
LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913
K093498 · DiaSorin, Inc. · Dec 2009