Cleared Traditional

K160370 - BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer (FDA 510(k) Clearance)

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

K160370 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Chemistry device

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Jun 2016

Decision

120d

Days

Class 2

Risk

K160370 is an FDA 510(k) clearance for the BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistr.... Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 9, 2016 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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	K160370 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 10, 2016
Decision Date	June 09, 2016
Days to Decision	120 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

32d slower than avg

Panel avg: 88d · This submission: 120d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	JGS Electrode, Ion Specific, Sodium
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 862.1665

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.