Cleared Traditional

K033851 - DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)

K033851 is an FDA 510(k) clearance for DIASCREEN REAGENT STRIPS FOR URINALYSIS, 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 82-day FDA review.

K033851 · Hypoguard USA, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
82d
Days
Class 2
Risk

K033851 is an FDA 510(k) clearance for the DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D1.... 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 March 2, 2004 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K033851

510(k) Number K033851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2003
Decision Date March 02, 2004
Days to Decision 82 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 88d · This submission: 82d
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 73
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K033851.
URYXXON 200 URINE ANALYZER
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URISCAN OPTIMA II URINE ANALYZER
K050801 · Yd Diagnostics · Apr 2005
CHEMVIEW-10
K042641 · Cenogenics Corp. · Jan 2005
COMBI-SCREEN, MODELS 10SL AND 11SL
K023885 · Analyticon Biotechnologies AG · Oct 2003
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
K032437 · Roche Diagnostics Corp. · Oct 2003
POCKETCHEM UA AUTION STICKS 10TA
K022386 · Arkray, Inc. · Sep 2002
K033851 · DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)
Download PDF FDA Summary Hypoguard USA, Inc.