Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)

K142220 · Nova Biomedical Corporation · CHL · Oct 17, 2014 · Clinical Chemistry

Device Facts

• Record ID: K142220
• Device Name: Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)
• Applicant: Nova Biomedical Corporation
• Product Code: CHL · Clinical Chemistry
• Decision Date: Oct 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Indications for Use

The Stat Profile Prime ABG Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, PCO2, and PO2 in heparinized whole blood. Stat Profile Prime Auto QC Cartridge ABG is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime ABG Analyzer. Stat Profile Prime Ampuled Control ABG/CCS is a quality control intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime ABG Analyzer. Stat Profile Prime Calibrator Cartridge ABG is intended for the calibration of pH, PCO2, and PO2, using the Stat Profile Prime ABG Analyzer.

Device Story

Stat Profile Prime ABG Analyzer is a microprocessor-based, benchtop blood gas analyzer for clinical laboratory use. It processes heparinized whole blood samples (syringes, tubes, capillary) aspirated via peristaltic pump into a disposable microsensor card. The card integrates sensors for pH (hydrogen ion-selective), PCO2 (Severinghaus-type), and PO2 (polarographic Clark-type). After analysis, samples are flushed into a waste bag within the disposable calibrator cartridge. The system features automated calibration using internal aqueous standards and automated quality control via internal auto-cartridge or external ampules. It includes a 5.7" color touchscreen, 1D/2D barcode scanner, and thermal printer. Healthcare professionals use the output to monitor acid-base status and guide clinical decision-making for patients with acid-base disturbances. The device is designed for easy customer installation and maintenance.

Clinical Evidence

Bench testing only. Method comparison study (N=150-187 per parameter) against predicate showed high correlation (r > 0.99) for pH, PCO2, and PO2. Precision studies (run-to-run and within-run) demonstrated acceptable SD and CV% across syringe and capillary modes. Linearity testing confirmed performance across the claimed measurement range. No clinical patient outcome data provided.

Technological Characteristics

Microprocessor-based analyzer; disposable microsensor card; peristaltic pump; 5.7" VGA touchscreen; thermal printer. Sensors: pH (hydrogen ion-selective), PCO2 (Severinghaus-type), PO2 (polarographic Clark-type). Connectivity: 1D/2D barcode scanner. Power: Electrical. Calibration/QC: Aqueous solutions in disposable Mylar bags. Standards: EN 61010-1, EN 61010-2-081, EN 61010-2-101.

Indications for Use

Indicated for healthcare professionals in clinical labs for quantitative determination of pH, PCO2, and PO2 in heparinized whole blood to diagnose and treat life-threatening acid-base disturbances.

Regulatory Classification

Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k142220

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.