Cleared Traditional

K960103 - DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS

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

K960103 · Dade Intl., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K960103

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
Combination Product No
PCCP Authorized No
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.

JIX Device Classification - Class 2, Special Controls

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 272
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
ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS
K960085 · Alko Diagnostic Corp. · Mar 1996
CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT
K955154 · Alko Diagnostic Corp. · Dec 1995
APOLIPOPROTEIN CALIBRATOR (APO-CAL)
K953979 · Beckman Instruments, Inc. · Oct 1995