(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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of a bird-like figure, possibly representing an eagle or other national symbol. The image is in black and white.
Public Health Service
JUN 2 5 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. James J. Miller Official Correspondent, General Manager Hemagen Diagnostics, Inc. Raichem Division 9033 Red Branch Road Columbia, MD 21045
K041009 Rc:
Trade/Device Name: Calcium (oCPC) test system Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CIC Dated: March 19, 2004 Reccived: April 19, 2004
Dear Mr. Miller:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreate) to regars actment date of the Medical Device Amendments, or to conniered prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, de vices mat nave been receasined in assee approval of a premarket approval application (PMA). and Costicule rice (110.) that do nover, subject to the general controls provisions of the Act. The r ou may, therefore, manver the act include requirements for annual registration, listing of general controls provisions of tactice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (660 ace re) arols. Existing major regulations affecting your device It may be subject to suen additional controllations (CFR), Parts 800 to 895. In addition, FDA can oc found in Trice 21, Socements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that I DA 3 losames or our device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any it catal statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the Tree STequire.Rents 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to begin mailiening of substantial equivalence of your device to a legally premarket notincation. The PDF imaling of your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, II you desire specific moormation association of your device, please contact the Office of of questions on the promotion and Safety at (301) 594-3084. Also, please note the In Ville Diagiosale Dorros 24aaaas reference to premarket notification" (21CFR Part 807.97). regulation chinaou, "Misorananang on your responsibilities under the Act from the Tood thay of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jain M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K041009
Device Name: Calcium (oCPC) test system
Indications For Use:
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 This calcium test system is a device intonuous and treatment of parathyroid
serum. Calcium measurements are used in the diagnosis and treatment serum. Calcidin measurements are are assurant in the arming of thempitent ulsease, a variety of bone diously, be intended patient population may be adult, pediatric, and neonatal.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K 041009
Page 1 of 1
§ 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.