Cleared Traditional

K942706 - ROCHE CALIBRATOR SERUM

K942706 is the FDA 510(k) clearance for ROCHE CALIBRATOR SERUM by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 469-day FDA review.

K942706 · Roche Diagnostic Systems, Inc. · Chemistry device
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Sep 1995
Decision
469d
Days
Class 2
Risk

K942706 is an FDA 510(k) clearance for the ROCHE CALIBRATOR SERUM. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on September 20, 1995 after a review of 469 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K942706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1994
Decision Date September 20, 1995
Days to Decision 469 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
381d slower than avg
Panel avg: 88d · This submission: 469d
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 K942706.
CALIBRATION SERUM LEVEL 1 & 2
K955489 · Randox Laboratories, Ltd. · Jun 1996
CEDIA CORE TDM MULTI-CAL
K961659 · Boehringer Mannheim Corp. · Jun 1996
APOLIPOPROTEIN CALIBRATOR (APO-CAL)
K953979 · Beckman Instruments, Inc. · Oct 1995
ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR
K952282 · 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