Cleared Traditional

K991176 - OPUS TROPONIN I CALIBRATOR

K991176 is the FDA 510(k) clearance for OPUS TROPONIN I CALIBRATOR by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K991176 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
85d
Days
Class 2
Risk

K991176 is an FDA 510(k) clearance for the OPUS TROPONIN I CALIBRATOR. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on July 1, 1999 after a review of 85 days - a notably fast clearance cycle.

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: 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K991176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1999
Decision Date July 01, 1999
Days to Decision 85 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
3d faster than avg
Panel avg: 88d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIT Calibrator, Secondary
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 - JIT Calibrator, Secondary

All 145
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K991176.
DIMENSION SPECIAL PROTEIN CALIBRATOR
K994291 · Dade Behring, Inc. · Mar 2000
ELECSYS ESTRADIOL CALSET II
K992981 · Roche Diagnostics Corp. · Sep 1999
N PROTEIN STANDARD UY
K991705 · Dade Behring, Inc. · Jul 1999
REVISED C-REACTIVE PROTEIN CALIBRATOR
K990824 · Dade Behring, Inc. · Apr 1999
DIMENSION SPECIAL PROTEIN CALIBRATOR
K990554 · Dade Behring, Inc. · Mar 1999
DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR
K984193 · Dade Behring, Inc. · Dec 1998