Cleared Traditional

K010973 - DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00

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

K010973 is an FDA 510(k) clearance for DIASCREEN 50 URINE CHEMISTRY ANALYZER, manufactured by Hypoguard USA, Inc.. The device is a Class 2 Chemistry device with product code JIL cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K010973 · Hypoguard USA, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K010973

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.

JIL Device Classification - Class 2, Special Controls

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)

All 46
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K010973.
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