Cleared Traditional

K920285 - BLOOD GAS/ISE LINEARITY CONTROL

K920285 is an FDA 510(k) clearance for BLOOD GAS/ISE LINEARITY CONTROL, manufactured by Phoenix Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JJS cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K920285 · Phoenix Diagnostics, Inc. · Chemistry device
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Jul 1992
Decision
174d
Days
Class 1
Risk

K920285 is an FDA 510(k) clearance for the BLOOD GAS/ISE LINEARITY CONTROL. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Phoenix Diagnostics, Inc. (Natick, US). The FDA issued a Cleared decision on July 14, 1992 after a review of 174 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Phoenix Diagnostics, Inc. devices

FDA 510(k) Submission Details - K920285

510(k) Number K920285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1992
Decision Date July 14, 1992
Days to Decision 174 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
86d slower than avg
Panel avg: 88d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

JJS Device Classification - Class 1, General Controls

Product Code JJS Controls For Blood-gases, (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJS Controls For Blood-gases, (assayed And Unassayed)

All 57
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K920285.
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