Cleared Special

K121224 - GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM

K121224 is an FDA 510(k) clearance for GENESIS HEALTH TECHNOLOGIES BLOOD GLUCO..., manufactured by Taidoc Technology Corporation. The device is a Class 2 Chemistry device with product code LFR cleared through the Special 510(k) pathway after a 152-day FDA review.

K121224 · Taidoc Technology Corporation · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
152d
Days
Class 2
Risk

K121224 is an FDA 510(k) clearance for the GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on September 19, 2012 after a review of 152 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K121224

510(k) Number K121224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2012
Decision Date September 19, 2012
Days to Decision 152 days
Submission Type Special
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
64d slower than avg
Panel avg: 88d · This submission: 152d
Pathway characteristics
Modification to existing cleared device.

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 72
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K121224.
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
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K113307 · Hmd Biomedical, Inc. · Jul 2012
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K121190 · Bayer Healthcare, LLC · Jul 2012
TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM
K120042 · Taidoc Technology Corporation · May 2012
K121224 · GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
Download PDF FDA Summary Taidoc Technology Cor…