Cleared Traditional

K870708 - GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM

K870708 is an FDA 510(k) clearance for GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM, manufactured by Kyoto Daiichi Kagaku Co., Ltd.. The device is a Class 2 Chemistry device with product code LFR cleared through the Traditional 510(k) pathway after a 347-day FDA review.

K870708 · Kyoto Daiichi Kagaku Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
347d
Days
Class 2
Risk

K870708 is an FDA 510(k) clearance for the GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Kyoto Daiichi Kagaku Co., Ltd. (Kyoto, 601, JP). The FDA issued a Cleared decision on February 2, 1988 after a review of 347 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Kyoto Daiichi Kagaku Co., Ltd. devices

FDA 510(k) Submission Details - K870708

510(k) Number K870708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1987
Decision Date February 02, 1988
Days to Decision 347 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
259d slower than avg
Panel avg: 88d · This submission: 347d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFR Device Classification - Class 2, Special Controls

Product Code LFR Glucose Dehydrogenase, 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 - LFR Glucose Dehydrogenase, Glucose

All 71
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K870708.
ACCU-CHEK ADVANTAGE TEST STRIPS
K954833 · Boehringer Mannheim Corp. · Feb 1996
GLUCOSE TEST ITEM NUMBER 97375/94
K951750 · Emd Chemicals, Inc. · Sep 1995
ADVANTAGE TEST STRIPS
K951887 · Boehringer Mannheim Corp. · Aug 1995
EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008
K874708 · Em Diagnostic Systems, Inc. · Dec 1987
ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID
K860726 · Trace Scientific , Ltd. · Apr 1986
EMDS GLUCOSE TEST PACK ITEM 67656/95
K855080 · Em Diagnostic Systems, Inc. · Feb 1986