Cleared Traditional

K823578 - COBAS STANDARDS FOR CALCIUM-IN-ORGANIC

K823578 is an FDA 510(k) clearance for COBAS STANDARDS FOR CALCIUM-IN-ORGANIC, manufactured by Hoffmann-La Roche, Inc.. The device is a Class 2 Chemistry device with product code CIO cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K823578 · Hoffmann-La Roche, Inc. · Chemistry device
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Jan 1983
Decision
32d
Days
Class 2
Risk

K823578 is an FDA 510(k) clearance for the COBAS STANDARDS FOR CALCIUM-IN-ORGANIC. Classified as Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes (product code CIO), Class II - Special Controls.

Submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1983 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hoffmann-La Roche, Inc. devices

FDA 510(k) Submission Details - K823578

510(k) Number K823578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1982
Decision Date January 07, 1983
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIO Device Classification - Class 2, Special Controls

Product Code CIO Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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 - CIO Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes

All 8
Devices cleared under the same product code (CIO) and FDA review panel - the closest regulatory comparables to K823578.
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