Cleared Special

K011126 - RAICHEM CREATININE URINE STANDARD

K011126 is the FDA 510(k) clearance for RAICHEM CREATININE URINE STANDARD by Hemagen Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Special 510(k) pathway after a 19-day FDA review.

K011126 · Hemagen Diagnostics, Inc. · Chemistry device
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May 2001
Decision
19d
Days
Class 2
Risk

K011126 is an FDA 510(k) clearance for the RAICHEM CREATININE URINE STANDARD. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on May 2, 2001 after a review of 19 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hemagen Diagnostics, Inc. devices

Submission Details

510(k) Number K011126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2001
Decision Date May 02, 2001
Days to Decision 19 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 88d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

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 159
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K011126.
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K003411 · Roche Diagnostics Corp. · Mar 2001