RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS

K122398 · Siemens Healthcare Diagnostics, Inc. · JIX · Oct 12, 2012 · Clinical Chemistry

Device Facts

• Record ID: K122398
• Device Name: RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Oct 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The RAPIDPoint® 500 System measurement cartridge with calibrators is an in vitro diagnostic product for the calibration of the analytes on the RAPIDPoint® 500 System. The analytes measured are partial pressure of carbon dioxide (pCO2), partial pressure of oxygen (pO2), pH, Sodium (Na *), Potassium (K'), ionized Calcium (Ca*), Chloride (Cl), Glucose (Glu), total hemoglobin (tHb), Neonatal Bilirubin (nBili) and Lactate (Lac).

Device Story

RAPIDPoint 500 System uses measurement and wash/waste cartridges containing aqueous salt solution calibrators; calibrates pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, tHb, and Lactate. Neonatal Bilirubin calibration is derived from tHb calibration. System operates in point-of-care settings; used by clinicians to ensure accuracy of blood analysis. Calibrator values assigned via flame photometry and mass spectrometry. Device ensures analytical accuracy for clinical decision-making regarding patient metabolic and respiratory status.

Clinical Evidence

Bench testing only. Stability protocols, value assignment procedures, and traceability to NIST reference materials were validated. No clinical data presented.

Technological Characteristics

Aqueous salt solution calibrators; liquid format. Traceable to NIST SRM reference materials (e.g., SRM186, 918, 919, 915, 917) and standard methods (e.g., flame photometry, hexokinase, coulometric, lactate dehydrogenase). Storage at 2-8°C or 2-30°C depending on component. Standalone cartridge system.

Indications for Use

Indicated for in vitro diagnostic calibration of blood gas, electrolyte, metabolite, and hemoglobin analytes on the RAPIDPoint 500 System. No specific patient population or contraindications provided.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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# Decision Summary

Statement for the Record, k122398.

This 510(k) was reviewed under OIVD’s Pilot Triage 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.