← Product Code [JIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX) · K963543 # SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2 (K963543) _Sigma Diagnostics, Inc. · JIX · Oct 30, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K963543 ## Device Facts - **Applicant:** Sigma Diagnostics, Inc. - **Product Code:** [JIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX.md) - **Decision Date:** Oct 30, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1150 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use Sigma Diagnostics CX®3 Calibration Standard Level 2 is used to calibrate the Beckman SYNCHRON CX®3 System. This reagent is used for the quantitative determination of BUN/urea, calcium, and total carbon dioxide in serum or plasma; of creatinine, potassium, and sodium in serum, plasma, or urine; and of chloride and glucose in serum, plasm, urine, or cerebrospinal fluid. Calibration Standard Level 2 should be used with CX®3 Calibration Standard Level 2. ## Device Story Calibration standard for Beckman SYNCHRON CX®3 clinical chemistry analyzer; contains specific concentrations of chloride, potassium, sodium, and total CO2; used in conjunction with Level 1 standard to establish calibration curves for quantitative analyte measurement; utilized in clinical laboratory settings by trained technicians; output enables accurate patient sample quantification; supports clinical decision-making regarding metabolic and electrolyte status. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Liquid reagent calibration standard; contains chloride (65 mmol/L), potassium (10.0 mmol/L), sodium (100 mmol/L), and total CO2 (30 mmol/L); non-reactive components included; designed for use with Beckman SYNCHRON CX®3 system. ## Regulatory 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. ## Predicate Devices - Beckman Calibration Standard 2 (Part No. 443365) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} k963543 510(k) NOTIFICATION Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103 CX®-3 Calibration Standard, Level 2 Procedure No. C7433 August 30, 1996 OCT 30 1996 # ATTACHMENT 1 ## Summary of Safety and Effectiveness {1} k963543 510(K) NOTIFICATION Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103 CX®3 Calibration Standard, Level 2 Procedure Number C7433 August 31, 1996 # SUMMARY OF SAFETY AND EFFECTIVENESS Sigma Diagnostics CX®3 Calibration Standard Level 2 is used to calibrate the Beckman SYNCHRON CX®3 System. This reagent is used for the quantitative determination of BUN/urea, calcium, and total carbon dioxide in serum or plasma; of creatinine, potassium, and sodium in serum, plasma, or urine; and of chloride and glucose in serum, plasm, urine, or cerebrospinal fluid. Calibration Standard Level 2 should be used with CX®3 Calibration Standard Level 1. CX®3 Calibration Standard Level 2 contains the following analytes and other non-reactive components: | ANALYTE | SI UNITS | | --- | --- | | Chloride | 65 mmol/L | | Potassium | 10.0 mmol/L | | Sodium | 100 mmol/L | | Total CO₂ | 30 mmol/L | The safety and effectiveness of Sigma Diagnostics CX®3 Calibration Standard, Level 2, Procedure Number C7433, are demonstrated by its substantial equivalency to Beckman Calibration Standard 2, Part No. 443365. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K963543](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K963543) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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