Cleared Special

K003012 - RAICHEM PHOSPORUS REAGENT

K003012 is an FDA 510(k) clearance for RAICHEM PHOSPORUS REAGENT, manufactured by Hemagen Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code CEO cleared through the Special 510(k) pathway after a 29-day FDA review.

K003012 · Hemagen Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
29d
Days
Class 1
Risk

K003012 is an FDA 510(k) clearance for the RAICHEM PHOSPORUS REAGENT. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on October 25, 2000 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1580 - 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.

FDA 510(k) Submission Details - K003012

510(k) Number K003012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2000
Decision Date October 25, 2000
Days to Decision 29 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
60d faster than avg
Panel avg: 89d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

CEO Device Classification - Class 1, General Controls

Product Code CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1580
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus

All 104
Devices cleared under the same product code (CEO) and FDA review panel - the closest regulatory comparables to K003012.
PICCOLO PHOSPHORUS TEST SYSTEM
K022312 · Abaxis, Inc. · Sep 2002
WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
K013095 · Wiener Laboratories Saic · Nov 2001
PHOSPHORUS REAGENT
K003912 · Jas Diagnostics, Inc. · Feb 2001
INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02
K991867 · A.P. Total Care, Inc. · Aug 1999
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347
K983503 · Boehringer Mannheim Corp. · Dec 1998
HICHEM PHOSPHORUS REAGENT KIT
K981769 · Elan Pharma, Inc. · Jun 1998
K003012 · RAICHEM PHOSPORUS REAGENT
Download PDF Hemagen Diagnostics, …