(67 days)
Not Found
Not Found
No
The summary describes a reagent for a quantitative chemical test and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is an in vitro diagnostic (IVD) test system used to measure calcium levels, which aids in diagnosis and treatment, but it does not directly provide therapy.
Yes
The text explicitly states, "Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany." This indicates the device aids in diagnosing medical conditions by measuring calcium levels.
No
The device is described as a "reagent" and a "calcium test system," which are typically physical components used in laboratory testing, not software. The description focuses on the chemical analysis of biological samples.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Purpose: The device is intended to measure a substance (Calcium) in biological samples (serum, heparinized plasma, or urine) to aid in the diagnosis and treatment of various medical conditions. This is the core function of an IVD.
N/A
Intended Use / 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 serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal failure, and tetany. Therefore, the intended patient population may be adult, pediatric, and neonatal.
Product codes
CIC
Device Description
Not Found
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
adult, pediatric, and neonatal.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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