Cleared Traditional

K003501 - N PROTEIN STANDARD UY CALIBRATOR

K003501 is an FDA 510(k) clearance for N PROTEIN STANDARD UY CALIBRATOR, manufactured by Dade Behring, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K003501

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.

JIT Device Classification - Class 2, Special Controls

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 208
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