Cleared Special

K110648 - NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM

K110648 is an FDA 510(k) clearance for NOVA STAT PROFILE PHOX ULTRA ANALYZER S..., manufactured by Nova Biomedical Corporation. The device is a Class 2 Chemistry device with product code CHL cleared through the Special 510(k) pathway after a 178-day FDA review.

K110648 · Nova Biomedical Corporation · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
178d
Days
Class 2
Risk

K110648 is an FDA 510(k) clearance for the NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Nova Biomedical Corporation (Waltham, US). The FDA issued a Cleared decision on August 29, 2011 after a review of 178 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K110648

510(k) Number K110648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2011
Decision Date August 29, 2011
Days to Decision 178 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 89d · This submission: 178d
Pathway characteristics
Modification to existing cleared device.

CHL Device Classification - Class 2, Special Controls

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
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 - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 186
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K110648.
ABL90 FLEX
K122642 · Radiometer Medical Aps · Oct 2012
COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B
K111188 · Roche Diagnostics · May 2012
ABL90 FLEX
K120197 · Radiometer Medical Aps · Mar 2012
ABL90
K111897 · Radiometer Medical Aps · Jul 2011
ABL835 FLEX ANALYZER WITH PLEURAL PH
K110416 · Radiometer Medical Aps · Mar 2011
OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561
K093280 · Opti Medical Systems, Inc. · Jan 2011
K110648 · NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
Download PDF FDA Summary Nova Biomedical Corpo…