(67 days)
This reagent is intended for the quantitative determination of Calcium in serum, heparinized plasma, or urine. For in vitro diagnostic use only.
This calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. The intended patient population may be adult, pediatric, and neonatal.
Not Found
Response to Request for Information on Device Acceptance Criteria and Study Details:
This document, K041009, is a 510(k) premarket notification for a Calcium (oCPC) test system. The information provided in this 510(k) letter is limited to the clearance of the device based on substantial equivalence to a predicate device. It does not contain the detailed study information or acceptance criteria that would typically be found in a more comprehensive submission or a clinical study report.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, and ground truth establishment cannot be extracted from this document alone. A 510(k) primarily focuses on demonstrating that a new device is as safe and effective as an already legally marketed device (the predicate).
However, I can extract what is explicitly stated or indirectly implied:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not report specific acceptance criteria or detailed device performance metrics such as sensitivity, specificity, accuracy, or precision. It states that the device is "substantially equivalent" to legally marketed predicate devices. This implies that its performance (accuracy, precision, linearity, etc.) is expected to be comparable to or within acceptable limits of the predicate device, but those specific values aren't listed here.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified in this document.
- Data Provenance: Not specified in this document. 510(k) submissions often include in-house validation data, but the details are not provided here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: Not applicable to this type of in vitro diagnostic device (reagent for chemical analysis). MRMC studies are typically used for imaging devices where human readers interpret results.
6. Standalone Performance Study (Algorithm Only):
- Standalone Performance: While the "Calcium (oCPC) test system" is an in vitro diagnostic device that produces a quantitative result, the document does not provide standalone performance data in terms of accuracy, precision, or other performance characteristics. The 510(k) process primarily evaluates substantial equivalence rather than requiring a detailed standalone clinical performance study to establish de novo effectiveness. Performance data would have been part of the full 510(k) submission, but is not included in this letter.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not specified in this document. For an in vitro diagnostic like a calcium test, the ground truth would typically be established by a reference method (e.g., atomic absorption spectroscopy) or comparison to an accepted, well-established clinical chemistry analyzer.
8. Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable in the context of this device and the information provided. This device is a chemical reagent-based test system, not an AI/algorithm-based system that uses a "training set" in the machine learning sense. Its performance is based on the chemical reactions and optical detection methods it employs.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth for Training Set Was Established: Not applicable (see point 8).
In summary: This 510(k) clearance letter confirms that the Calcium (oCPC) test system was deemed "substantially equivalent" to a predicate device for its intended use (quantitative determination of Calcium in serum, heparinized plasma, or urine, for in vitro diagnostic use, to aid in diagnosis and treatment of conditions like parathyroid disease). However, it does not provide the detailed study results, specific performance metrics, or method validation data that would be found within the full 510(k) submission.
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.