(55 days)
Not Found
Not Found
No
The device is a calibration standard, a chemical reagent used to calibrate a laboratory instrument. There is no indication of software or algorithms, let alone AI/ML.
No
This device is a calibration standard used to calibrate a diagnostic system, not to provide therapy or treatment.
No
This device is a calibration standard used to calibrate another system (Beckman SYNCHRON CX 3 System), which then performs the diagnostic measurements. The calibration standard itself does not directly perform diagnosis; it ensures the accuracy of the diagnostic device.
No
The device description clearly states it is a "Calibration Standard" containing various analytes, which are chemical substances used for calibration. This indicates a physical reagent, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is used to "calibrate the Beckman SYNCHRON CX 3 System" 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." These are all measurements performed on biological samples in vitro (outside the body) to provide information for diagnostic purposes.
- Device Description: The device contains specific analytes at known concentrations, which are typical components of calibration standards used in in vitro diagnostic testing.
- Performance Studies: The summary of performance studies mentions demonstrating "substantial equivalency" to a predicate device, which is a common regulatory pathway for IVDs.
- Predicate Device: The mention of a "Predicate Device" (Beckman Calibration Standard 1) further confirms its classification as a medical device, and given its function, specifically an IVD.
The core function of a calibration standard in this context is to ensure the accuracy of an analytical instrument (the Beckman SYNCHRON CX 3 System) that is used for in vitro diagnostic testing. Therefore, the calibration standard itself is considered an IVD accessory or component.
N/A
Intended Use / 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.
Product codes
Not Found
Device Description
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 |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Beckman Calibration Standard 1, Part No. 443360
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1150 Calibrator.
(a)
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.)(b)
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.
0
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.