Cleared Traditional

GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM (K870708) - FDA 510(k) Clearance

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

K870708 · Kyoto Daiichi Kagaku Co., Ltd. · Chemistry device
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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

Submission Details

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.

Device Classification

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 72
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K870708.
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ACCU-CHEK GO SYSTEM
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