Cleared Traditional

K080643 - ELECSYS ANTI-TSHR CALCHECK

K080643 is an FDA 510(k) clearance for ELECSYS ANTI-TSHR CALCHECK, manufactured by Roche Diagnostics. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K080643 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
169d
Days
Class 1
Risk

K080643 is an FDA 510(k) clearance for the ELECSYS ANTI-TSHR 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 August 22, 2008 after a review of 169 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.

FDA 510(k) Submission Details - K080643

510(k) Number K080643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2008
Decision Date August 22, 2008
Days to Decision 169 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
80d slower than avg
Panel avg: 89d · This submission: 169d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

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 492
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K080643.
ABT GLUCOSE CONTROL SOLUTION
K083549 · American Biological Technologies, Inc. · Dec 2008
RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS
K081478 · Bionostics, Inc. · Oct 2008
GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002
K082395 · Bionostics, Inc. · Sep 2008
AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION
K080273 · Fujirebio Diagnostics Texas, Inc. · Aug 2008
FDTX GLUCOSE CONTROL SOLUTION
K081915 · Fujirebio Diagnostics Texas, Inc. · Aug 2008
GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK
K081403 · Bionostics, Inc. · Jul 2008
K080643 · ELECSYS ANTI-TSHR CALCHECK
Download PDF FDA Summary Roche Diagnostics