Cleared Traditional

K113007 - BIONIME DIABETES MANAGEMENT SYSTEM VI.0

K113007 is an FDA 510(k) clearance for BIONIME DIABETES MANAGEMENT SYSTEM VI.0, manufactured by Bionime Corporation. The device is a Class 1 Chemistry device with product code JQP cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K113007 · Bionime Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
143d
Days
Class 1
Risk

K113007 is an FDA 510(k) clearance for the BIONIME DIABETES MANAGEMENT SYSTEM VI.0. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Bionime Corporation (Mission Viejo, US). The FDA issued a Cleared decision on February 27, 2012 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2100 - 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 Bionime Corporation devices

FDA 510(k) Submission Details - K113007

510(k) Number K113007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2011
Decision Date February 27, 2012
Days to Decision 143 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 88d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

JQP Device Classification - Class 1, General Controls

Product Code JQP Calculator/data Processing Module, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JQP Calculator/data Processing Module, For Clinical Use

All 55
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K113007.
FASTTAKE ADAPTER, MODEL # P/N 020-072-01
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THE ROBOLITE
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MR7000 WITH TIME MANAGER SOFTWARE (TMS)
K934111 · Dynatech Laboratories, Inc. · Nov 1994
EXPRESSO CARTRIDGE
K923316 · Bio-Rad Laboratories, Inc. · Feb 1993
MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER
K893838 · Ciba Corning Diagnostics Corp. · Aug 1989
CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM
K892060 · Syva Co. · Aug 1989