Cleared Traditional

K192730 - CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV

K192730 is an FDA 510(k) clearance for CALCIUM-CRESOLPHTHALEIN, manufactured by Biosystems S.A.. The device is a Class 2 Chemistry device with product code CHW cleared through the Traditional 510(k) pathway after a 348-day FDA review.

K192730 · Biosystems S.A. · Chemistry device
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Sep 2020
Decision
348d
Days
Class 2
Risk

K192730 is an FDA 510(k) clearance for the CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV. Classified as Titrimetric With Edta And Indicator, Calcium (product code CHW), Class II - Special Controls.

Submitted by Biosystems S.A. (Barcelona, ES). The FDA issued a Cleared decision on September 9, 2020 after a review of 348 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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. Elevated predicate reliance profile. 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 Biosystems S.A. devices

FDA 510(k) Submission Details - K192730

510(k) Number K192730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2019
Decision Date September 09, 2020
Days to Decision 348 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
260d slower than avg
Panel avg: 88d · This submission: 348d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CHW Device Classification - Class 2, Special Controls

Product Code CHW Titrimetric With Edta And Indicator, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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.