Cleared Traditional

K960103 - DADE MONI-TROL CANDIDATE PRODUCT COMBIN...

K960103 is the FDA 510(k) clearance for DADE MONI-TROL CANDIDATE PRODUCT COMBIN... by Dade Intl., Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K960103 · Dade Intl., Inc. · Chemistry device
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Apr 1996
Decision
106d
Days
Class 2
Risk

K960103 is an FDA 510(k) clearance for the DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Dade Intl., Inc. (Miami, US). The FDA issued a Cleared decision on April 26, 1996 after a review of 106 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 Dade Intl., Inc. devices

Submission Details

510(k) Number K960103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1996
Decision Date April 26, 1996
Days to Decision 106 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 88d · This submission: 106d
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 202
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K960103.
N PROTEIN STANDARD PY
K962410 · Behring Diagnostics, Inc. · Jul 1996
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 CALIBRATOR SERUM
K942706 · Roche Diagnostic Systems, Inc. · Sep 1995
ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR
K952282 · Roche Diagnostic Systems, Inc. · Sep 1995