Cleared Traditional

K952282 - ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR

K952282 is the FDA 510(k) clearance for ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K952282 · Roche Diagnostic Systems, Inc. · Chemistry device
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Sep 1995
Decision
122d
Days
Class 2
Risk

K952282 is an FDA 510(k) clearance for the ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on September 15, 1995 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K952282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1995
Decision Date September 15, 1995
Days to Decision 122 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 88d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 183
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K952282.
CEDIA CORE TDM MULTI-CAL
K961659 · Boehringer Mannheim Corp. · Jun 1996
APOLIPOPROTEIN CALIBRATOR (APO-CAL)
K953979 · Beckman Instruments, Inc. · Oct 1995
ROCHE CALIBRATOR SERUM
K942706 · Roche Diagnostic Systems, Inc. · Sep 1995
SYNERMEDIR CAL I AND SYNERMED IR CAL II
K940571 · Synermed, Inc. · Apr 1994
ACA PLUS FERRITIN CALIBRATOR
K935543 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1994
CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323
K932768 · Helena Laboratories · Oct 1993