(56 days)
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No
The document describes a calibration standard for a laboratory analyzer, which is a chemical reagent, not a software or hardware device that would typically incorporate AI/ML. The text explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is a calibration standard used to calibrate a diagnostic system, not to treat a medical condition.
No
Explanation: This device is a calibration standard used to calibrate a diagnostic system, not a diagnostic device itself. It contains known concentrations of analytes to ensure the accuracy of the diagnostic instrument.
No
The device is a calibration standard, which is a physical reagent used to calibrate a laboratory instrument. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that it is used to calibrate a system (Beckman SYNCHRON CX®3 System) for the quantitative determination of various analytes (BUN/urea, calcium, total carbon dioxide, creatinine, potassium, sodium, chloride, and glucose) in biological samples (serum, plasma, urine, cerebrospinal fluid). This is a classic description of an IVD device used in a laboratory setting to perform diagnostic tests.
- Device Description: The description lists the specific analytes and their concentrations within the standard, which are used to establish a known reference point for the analytical system. This is consistent with the nature of a calibration standard used in IVD testing.
- Predicate Device: The mention of a predicate device (Beckman Calibration Standard 2) further supports its classification as an IVD, as predicate devices are used to demonstrate substantial equivalence for regulatory purposes within the IVD framework.
Calibration standards like this are essential components of IVD systems, ensuring the accuracy and reliability of the diagnostic results obtained from patient samples.
N/A
Intended Use / 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 1.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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 |
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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
મું વિ
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.