Cleared Traditional

K905477 - OLYMPUS URINE PH CALIBRATORS LEVELS I A...

K905477 is the FDA 510(k) clearance for OLYMPUS URINE PH CALIBRATORS LEVELS I A... by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K905477 · Em Diagnostic Systems, Inc. · Chemistry device
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Feb 1991
Decision
69d
Days
Class 2
Risk

K905477 is an FDA 510(k) clearance for the OLYMPUS URINE PH CALIBRATORS LEVELS I AND II. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on February 13, 1991 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K905477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1990
Decision Date February 13, 1991
Days to Decision 69 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
19d faster than avg
Panel avg: 88d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIS Calibrator, Primary

All 93
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K905477.
KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD
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RAICHEM(TM) BILIRUBIN STANDARD
K882726 · Reagents Applications, Inc. · Aug 1988
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K881693 · Terumo Medical Corp. · Jun 1988