Cleared Traditional

K952477 - STAT PROFILE ULTRA BLOOD GAS CONTROLS

K952477 is the FDA 510(k) clearance for STAT PROFILE ULTRA BLOOD GAS CONTROLS by Nova Biomedical Corp.. It is a Class 1 Chemistry device (product code JJS) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K952477 · Nova Biomedical Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
37d
Days
Class 1
Risk

K952477 is an FDA 510(k) clearance for the STAT PROFILE ULTRA BLOOD GAS CONTROLS. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on July 6, 1995 after a review of 37 days - a notably fast clearance 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: 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 Nova Biomedical Corp. devices

Submission Details

510(k) Number K952477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1995
Decision Date July 06, 1995
Days to Decision 37 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
51d faster than avg
Panel avg: 88d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 41
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K952477.
QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)
K961354 · Radiometer America, Inc. · Jun 1996
MULTICHECK
K961355 · Radiometer America, Inc. · Jun 1996
QUALICHECK 4 GLUCOSE
K952637 · Radiometer America, Inc. · Sep 1995
CERTAIN(R) ELITE LEVEL 1, 2 AND 3
K946224 · Ciba Corning Diagnostics Corp. · Jan 1995
MULTICHECK(TM)
K935515 · Radiometer America, Inc. · Apr 1994
MICROBACT SOLID PLATE SYSTEMS
K923342 · Radiometer America, Inc. · Sep 1992