Cleared Traditional

K072018 - BS-200 CHEMISTRY ANALYZER

K072018 is the FDA 510(k) clearance for BS-200 CHEMISTRY ANALYZER by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K072018 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Chemistry device
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Feb 2008
Decision
193d
Days
Class 2
Risk

K072018 is an FDA 510(k) clearance for the BS-200 CHEMISTRY ANALYZER, MODE BS-200. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on February 1, 2008 after a review of 193 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 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. devices

Submission Details

510(k) Number K072018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2007
Decision Date February 01, 2008
Days to Decision 193 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
105d slower than avg
Panel avg: 88d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFR Hexokinase, 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 - CFR Hexokinase, Glucose

All 107
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K072018.
COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY
K092603 · Roche Diagnostics · Dec 2009
EASYRA GLU-H REAGENT, MODEL 10200
K092506 · Medica Corp. · Sep 2009
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
K080123 · Wako Chemicals USA, Inc. · Jul 2008
POINTE 360
K062118 · Pointe Scientific, Inc., · Jul 2007
GLUCOSE HK NEW FORMULATION TEST SYSTEM
K062239 · Roche Diagnostics Corp. · Sep 2006
COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
K061048 · Roche Diagnostics Corp. · May 2006