Cleared Traditional

K994291 - DIMENSION SPECIAL PROTEIN CALIBRATOR

K994291 is the FDA 510(k) clearance for DIMENSION SPECIAL PROTEIN CALIBRATOR by Dade Behring, Inc.. It is a Class 2 Immunology device (product code JIT) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K994291 · Dade Behring, Inc. · Immunology device
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Mar 2000
Decision
71d
Days
Class 2
Risk

K994291 is an FDA 510(k) clearance for the DIMENSION SPECIAL PROTEIN 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 March 1, 2000 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - the FDA immunology 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K994291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1999
Decision Date March 01, 2000
Days to Decision 71 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 104d · This submission: 71d
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 Immunology 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 K994291.
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
K010208 · Dade Behring, Inc. · Feb 2001
ELECSYS FSH CALSET II
K003409 · Roche Diagnostics Corp. · Jan 2001
ACCESS ULTRASENSITIVE HGH CALIBRATORS
K003098 · Beckman Coulter, Inc. · Nov 2000
ELECSYS ESTRADIOL CALSET II
K992981 · Roche Diagnostics Corp. · Sep 1999
N PROTEIN STANDARD UY
K991705 · Dade Behring, Inc. · Jul 1999
OPUS TROPONIN I CALIBRATOR
K991176 · Dade Behring, Inc. · Jul 1999