SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS by ARKRAY, INC.

The SpotChem II Calcium test is intended to measure the concentration of calcium in serum, plasma and whole blood. 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).

The SpotChem II Magnesium test is intended to measure the concentration of magnesium in serum, plasma and whole blood. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

The SpotChem II Blood Urea Nitrogen (BUN) test is intended to measure the concentration of urea nitrogen in serum, plasma and whole blood. Blood urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for the Arkray SpotChem II Calcium, Magnesium, and Blood Urea Nitrogen Tests. This type of document declares substantial equivalence to a predicate device and does not typically include detailed studies proving device performance against specific acceptance criteria. The information requested, such as sample size, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is usually found within the 510(k) submission itself (which is not provided) or in detailed clinical study reports, not in the FDA's clearance letter.

Therefore,Based on the provided FDA 510(k) clearance letter, I cannot provide the detailed information requested regarding the acceptance criteria and the study that proves the device meets those criteria.

Here's why:

Nature of the Document: This document is an FDA clearance letter, which states that the device is "substantially equivalent" to legally marketed predicate devices. It does not contain the detailed study results, acceptance criteria, or methodological specifics that were submitted to the FDA to demonstrate this substantial equivalence. These details would be in the original 510(k) submission, which is not provided.
Information Not Present: The letter does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or expert qualifications for ground truth.
- Adjudication methods.
- Information about multi-reader multi-case (MRMC) studies or standalone performance.
- Details on the type of ground truth used or the sample size and ground truth establishment for the training set.

The letter mentions that the FDA reviewed the premarket notification, implying that such studies and acceptance criteria were part of that submission. However, the clearance letter itself only states the FDA's decision based on that review.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 5 2005

Arkay, Inc. c/o Helen Landicho, RAC Director of Regulatory Affairs Polymedco, Inc. 510 Furnace Dock Road Cortlandt Manor, NY 10567

K050077 Re:

Trade/Device Name: Arkray SpotChem II Calcium, Magnesium, and Blood Urea Nitrogen Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CIC, JGJ, JGZ Dated: January 11, 2005 Received: January 12, 2005

Dear Ms. Landicho:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practicc requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{1}------------------------------------------------

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permite your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division 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/industry/support/index.html

Sincerely yours,

Sean McCogen, MS, DVM

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Fivaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known): K050077

Device Name: Arkray SpotChem II Calcium, Magnesium, and Blood Urea Nitrogen Tests

Indications For Use:

Prescription Use (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)

Division Sign Off

Page 1 of 1

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K13007

Regulation Number and Section

§ 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.