Cleared Traditional

K110571 - TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE

K110571 is an FDA 510(k) clearance for TELCARE BLOOD GLUCOSE MONITORING SYSTEM, manufactured by Telcare, Inc.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K110571 · Telcare, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
149d
Days
Class 2
Risk

K110571 is an FDA 510(k) clearance for the TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELS.... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Telcare, Inc. (Bethesda, US). The FDA issued a Cleared decision on July 28, 2011 after a review of 149 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.

FDA 510(k) Submission Details - K110571

510(k) Number K110571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2011
Decision Date July 28, 2011
Days to Decision 149 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
61d slower than avg
Panel avg: 88d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBW Device Classification - Class 2, Special Controls

Product Code NBW System, Test, Blood Glucose, Over The Counter
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 - NBW System, Test, Blood Glucose, Over The Counter

All 510
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K110571.
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AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM
K093755 · Andon Medical Co., Ltd. · Jul 2011
FORA POCT MANAGMENT SYSTEM
K111029 · Taidoc Technology Corporation · Jul 2011
U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM
K101509 · Taidoc Technology Corporation · Jun 2011
K110571 · TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE
Download PDF FDA Summary Telcare, Inc.