Cleared Traditional

DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00 (K010973) - FDA 510(k) Clearance

Also marketed or referenced as:
DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K010973 · Hypoguard USA, Inc. · Chemistry device
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Sep 2001
Decision
162d
Days
Class 2
Risk

K010973 is an FDA 510(k) clearance for the DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Hypoguard USA, Inc. (Edina, US). The FDA issued a Cleared decision on September 11, 2001 after a review of 162 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1340 - 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 Hypoguard USA, Inc. devices

Submission Details

510(k) Number K010973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2001
Decision Date September 11, 2001
Days to Decision 162 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
74d slower than avg
Panel avg: 88d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1340
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 - JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)

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