Cleared Traditional

K991800 - HEMOCHEK URINE COLLECTION KIT

K991800 is the FDA 510(k) clearance for HEMOCHEK URINE COLLECTION KIT by Osborn Group, Inc.. It is a Class 1 Chemistry device (product code JIQ) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K991800 · Osborn Group, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Sep 1999
Decision
121d
Days
Class 1
Risk

K991800 is an FDA 510(k) clearance for the HEMOCHEK URINE COLLECTION KIT. Classified as Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (product code JIQ), Class I - General Controls.

Submitted by Osborn Group, Inc. (Olathe, US). The FDA issued a Cleared decision on September 24, 1999 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1645 - 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 Osborn Group, Inc. devices

Submission Details

510(k) Number K991800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1999
Decision Date September 24, 1999
Days to Decision 121 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 88d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIQ Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1645
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 - JIQ Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)

All 8
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