MTM BIOSCANNER K TEST STRIPS

• K Number: K981865
• Device Name: MTM BIOSCANNER K TEST STRIPS
• Manufacturer: POLYMER TECHNOLOGY SYSTEMS, INC.
• Date Cleared: 1999-02-26 ( 274 days)
• Product Code: JMK
• Regulation Number: 862.1380
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The MTM Bio Scanner K Test Strip is intended for the in vitro diagnostic quantitative screening for Ketones in whole blood, serum and plasma in physicians' office laboratories and at bedside in acute and convalescent care facilities to screen for ketosis and Diabetic Ketoacidosis.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain the detailed information about acceptance criteria, study design, or performance evaluations as requested in your prompt. This type of document is a regulatory approval, not a scientific study report.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance results
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

The document only states that the device, "MTM Bio Scanner K Test Strips," is intended for "in vitro diagnostic quantitative screening for Ketones in whole blood, serum, and plasma in physicians' office laboratories and at bedside... to screen for ketosis and Diabetic Ketoacidosis" and that it was deemed "substantially equivalent" to predicate devices. This substantial equivalence determination would typically be based on data reviewed by the FDA, but that data itself is not included in this letter.

Regulation Number and Section

§ 862.1380 Hydroxybutyric dehydrogenase test system.

(a)
Identification. A hydroxybutyric dehydrogenase test system is a device intended to measure the activity of the enzyme alpha-hydroxybutric dehydrogenase (HBD) in plasma or serum. HBD measurements are used in the diagnosis and treatment of myocardial infarction, renal damage (such as rejection of transplants), certain hematological diseases (such as acute leukemias and megaloblastic anemias) and, to a lesser degree, liver disease.(b)
Classification. Class I (general 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.