Cleared Traditional

K102157 - ELECSYS PRECICONTROL MULTIMARKER

K102157 is the FDA 510(k) clearance for ELECSYS PRECICONTROL MULTIMARKER by Roche Diagnostics. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K102157 · Roche Diagnostics · Chemistry device
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Aug 2010
Decision
28d
Days
Class 1
Risk

K102157 is an FDA 510(k) clearance for the ELECSYS PRECICONTROL MULTIMARKER. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on August 27, 2010 after a review of 28 days - a notably fast clearance 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: 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 K102157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2010
Decision Date August 27, 2010
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 380
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K102157.
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TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET
K093032 · Biosite Incorporated · Nov 2009
ELECSYS PRECICONTROL THYROAB
K092320 · Roche Diagnostics · Nov 2009
THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158
K092051 · Microgenics Corp. · Sep 2009