Cleared Traditional

K083655 - ELECSYS TOXO IGG CALCHECK

K083655 is the FDA 510(k) clearance for ELECSYS TOXO IGG CALCHECK by Roche Diagnostics. It is a Class 1 Microbiology device (product code JJX) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K083655 · Roche Diagnostics · Microbiology device
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Feb 2009
Decision
64d
Days
Class 1
Risk

K083655 is an FDA 510(k) clearance for the ELECSYS TOXO IGG CALCHECK. 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 February 12, 2009 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1660 - the FDA microbiology 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: 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 Roche Diagnostics devices

Submission Details

510(k) Number K083655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2008
Decision Date February 12, 2009
Days to Decision 64 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 102d · This submission: 64d
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 370
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K083655.
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K080643 · Roche Diagnostics · Aug 2008