Cleared Traditional

UROTEST GPH (K912244) - FDA 510(k) Clearance

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

K912244 · In Wha Pharmaceutical Co., Ltd. · Chemistry device
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Nov 1991
Decision
185d
Days
Class 2
Risk

K912244 is an FDA 510(k) clearance for the UROTEST GPH. Classified as Atomic Absorption, Lithium (product code JII), Class II - Special Controls.

Submitted by In Wha Pharmaceutical Co., Ltd. (Korea, KR). The FDA issued a Cleared decision on November 22, 1991 after a review of 185 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3560 - 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 In Wha Pharmaceutical Co., Ltd. devices

Submission Details

510(k) Number K912244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1991
Decision Date November 22, 1991
Days to Decision 185 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 88d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JII Atomic Absorption, Lithium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3560
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.