Cleared Traditional

K952307 - BIOSCAN

K952307 is an FDA 510(k) clearance for BIOSCAN, manufactured by Biosys Laboratories, Inc.. The device is a Class 2 Chemistry device with product code JIL cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K952307 · Biosys Laboratories, Inc. · Chemistry device
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Sep 1995
Decision
111d
Days
Class 2
Risk

K952307 is an FDA 510(k) clearance for the BIOSCAN. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Biosys Laboratories, Inc. (Los Angeles, US). The FDA issued a Cleared decision on September 5, 1995 after a review of 111 days - within the typical 510(k) review window.

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 Biosys Laboratories, Inc. devices

FDA 510(k) Submission Details - K952307

510(k) Number K952307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1995
Decision Date September 05, 1995
Days to Decision 111 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
23d slower than avg
Panel avg: 88d · This submission: 111d
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 56
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K952307.
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IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET
K942648 · Teco Diagnostics · Mar 1995
URINE REAGENT STRIP-3 PARAMETERS
K940469 · Teco Diagnostics · Sep 1994
CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS
K896454 · Boehringer Mannheim Corp. · Jan 1990