Cleared Traditional

K910692 - BIO SCAN-BG(TM

K910692 is an FDA 510(k) clearance for BIO SCAN-BG(TM, manufactured by Bio Scan Instrument, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K910692 · Bio Scan Instrument, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
38d
Days
Class 2
Risk

K910692 is an FDA 510(k) clearance for the BIO SCAN-BG(TM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Bio Scan Instrument, Inc. (New York, US). The FDA issued a Cleared decision on March 29, 1991 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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.

View all Bio Scan Instrument, Inc. devices

FDA 510(k) Submission Details - K910692

510(k) Number K910692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1991
Decision Date March 29, 1991
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CGA Glucose Oxidase, Glucose

All 313
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K910692.
ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K912440 · Home Diagnostics, Inc. · Jul 1991
FIRST CHOICE(TM), MODIFICATION
K911792 · Polymer Technology Corp. · May 1991
YSI MODEL 1500 BLOOD GLUCOSE ANALYZER
K910633 · Yellow Springs Instrument Co., Inc. · Apr 1991
GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM
K904081 · Heraeus Kulzer, Inc. · Dec 1990
CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST
K904082 · Cholestech Corp. · Dec 1990
ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM
K904292 · Boehringer Mannheim Corp. · Oct 1990