Cleared Traditional

K961985 - ELECT BLOOD GLUCOSE MONITORIG SYSTEM

K961985 is an FDA 510(k) clearance for ELECT BLOOD GLUCOSE MONITORIG SYSTEM, manufactured by Selfcare, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K961985 · Selfcare, Inc. · Chemistry device
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Sep 1996
Decision
107d
Days
Class 2
Risk

K961985 is an FDA 510(k) clearance for the ELECT BLOOD GLUCOSE MONITORIG SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Selfcare, Inc. (Waltham, US). The FDA issued a Cleared decision on September 5, 1996 after a review of 107 days - within the typical 510(k) review window.

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. 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 Selfcare, Inc. devices

FDA 510(k) Submission Details - K961985

510(k) Number K961985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1996
Decision Date September 05, 1996
Days to Decision 107 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 88d · This submission: 107d
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 273
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K961985.
GLUCOMETER DEX DIABETES CARE SYSTEM
K963500 · Bayer Corp. · Jan 1997
SIGMA DIAGNOSTICS GLUCOSE REAGENT
K963535 · Sigma Diagnostics, Inc. · Jan 1997
PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL
K960855 · Home Diagnostics, Inc. · Nov 1996
EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)
K955286 · Johnson & Johnson Clinical Diagnostics, Inc. · May 1996
ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM
K944459 · Boehringer Mannheim Corp. · Apr 1996
ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS
K952875 · Boehringer Mannheim Corp. · Nov 1995