← Product Code [JIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX) · K963533 # SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1 (K963533) _Sigma Diagnostics, Inc. · JIX · Oct 29, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K963533 ## Device Facts - **Applicant:** Sigma Diagnostics, Inc. - **Product Code:** [JIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX.md) - **Decision Date:** Oct 29, 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 1 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, plasma, urine, or cerebrospinal fluid. Calibration Standard Level 1 should be used with CX®3 Calibration Standard Level 2. ## Device Story Calibration reagent for Beckman SYNCHRON CX®3 clinical chemistry analyzer; contains defined concentrations of BUN/urea, calcium, total CO2, creatinine, potassium, sodium, chloride, and glucose; used in clinical laboratory settings by trained personnel; ensures system accuracy for quantitative diagnostic testing; functions as reference standard for instrument calibration; supports clinical decision-making by maintaining analytical precision of patient sample measurements. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Liquid reagent containing specified concentrations of analytes (Calcium, Chloride, Creatinine, Glucose, Potassium, Sodium, Urea, BUN); intended for use with Beckman SYNCHRON CX®3 System; non-reactive components included; no specific materials or software algorithms described. ## 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 1 (Part No. 443360) ## 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} K963533 OCT 29 1996 510(K) NOTIFICATION Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103 CX®3 Calibration Standard, Level 1 Procedure Number C7308 August 31, 1996 # SUMMARY OF SAFETY AND EFFECTIVENESS Sigma Diagnostics CX®3 Calibration Standard Level 1 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, plasma, urine, or cerebrospinal fluid. Calibration Standard Level 1 should be used with CX®3 Calibration Standard Level 2. CX®3 Calibration Standard Level 1 contains the following analytes and other non-reactive components: | ANALYTE | CONVENTIONAL UNITS | SI UNITS | | --- | --- | --- | | Calcium | 10.0 mg/dL | 2.495 mmol/L | | Chloride | 109 mmol/L | 109 mmol/L | | Creatinine | 5.0 mg/dL | 442 umol/L | | Glucose | 150 mg/dL | 8.34 mmol/L | | Potassium | 4.0 mmol/L | 4.0 mmol/L | | Sodium | 150 mmol/L | 150 mmol/L | | Urea | 107 mg/dL | 17.8 mmol/L | | BUN (Urea Nitrogen) | 50 mg/dL | 17.8 mmol/L | The safety and effectiveness of Sigma Diagnostics CX®3 Calibration Standard, Level 1, Procedure Number C7308, are demonstrated by its substantial equivalency to Beckman Calibration Standard 1, Part No. 443360. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K963533](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K963533) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com