Cleared Traditional

GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS (K121433) - FDA 510(k) Clearance

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

K121433 · Hmd Biomedical, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
276d
Days
Class 2
Risk

K121433 is an FDA 510(k) clearance for the GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT U.... Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Hmd Biomedical, Inc. (Xinpu Township, Hsinchu County, TW). The FDA issued a Cleared decision on February 14, 2013 after a review of 276 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. 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 Hmd Biomedical, Inc. devices

Submission Details

510(k) Number K121433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2012
Decision Date February 14, 2013
Days to Decision 276 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
188d slower than avg
Panel avg: 88d · This submission: 276d
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 33
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K121433.
GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
K121224 · Taidoc Technology Corporation · Sep 2012
TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM
K120042 · Taidoc Technology Corporation · May 2012
U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM
K113768 · Taidoc Technology Corporation · Apr 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
K111874 · Abbott Laboratories · Feb 2012
ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM
K101299 · Roche Diagnostics · Sep 2011
FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM
K092688 · Taidoc Technology Corporation · Jul 2011