Cleared Traditional

K003501 - N PROTEIN STANDARD UY CALIBRATOR

K003501 is the FDA 510(k) clearance for N PROTEIN STANDARD UY CALIBRATOR by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K003501 · Dade Behring, Inc. · Chemistry device
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Mar 2001
Decision
122d
Days
Class 2
Risk

K003501 is an FDA 510(k) clearance for the N PROTEIN STANDARD UY CALIBRATOR. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on March 15, 2001 after a review of 122 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 Behring, Inc. devices

Submission Details

510(k) Number K003501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2000
Decision Date March 15, 2001
Days to Decision 122 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
34d slower than avg
Panel avg: 88d · This submission: 122d
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 K003501.
WAKO LIPID CALIBRATOR
K010334 · Wako Chemicals USA, Inc. · Jun 2001
RAICHEM CREATININE URINE STANDARD
K011126 · Hemagen Diagnostics, Inc. · May 2001
DIMENSION CTNI CALIBRATOR
K010314 · Dade Behring, Inc. · Apr 2001
ELECSYS TESTOSTERONE CALSET II
K003411 · Roche Diagnostics Corp. · Mar 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
K010208 · Dade Behring, Inc. · Feb 2001
ELECSYS FSH CALSET II
K003409 · Roche Diagnostics Corp. · Jan 2001