Cleared Traditional

K961659 - CEDIA CORE TDM MULTI-CAL

K961659 is an FDA 510(k) clearance for CEDIA CORE TDM MULTI-CAL, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Toxicology device with product code JIX cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K961659 · Boehringer Mannheim Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
44d
Days
Class 2
Risk

K961659 is an FDA 510(k) clearance for the CEDIA CORE TDM MULTI-CAL. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Columbus, US). The FDA issued a Cleared decision on June 13, 1996 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1150 - the FDA toxicology device 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K961659

510(k) Number K961659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1996
Decision Date June 13, 1996
Days to Decision 44 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 87d · This submission: 44d
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 Toxicology devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 230
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K961659.
N CRP STANDARD SY
K962406 · Behring Diagnostics, Inc. · Jul 1996
N PROTEIN STANDARD PY
K962410 · Behring Diagnostics, Inc. · Jul 1996
CALIBRATION SERUM LEVEL 1 & 2
K955489 · Randox Laboratories, Ltd. · Jun 1996
DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS
K960103 · Dade Intl., Inc. · Apr 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