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The Scantibodies Laboratory Inc. Calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thryocalcitonin) levels in serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).

Device Description

Calcitonin Immunoradiometric Assay (IRMA) (Coated Tube Version)

AI/ML Overview

I am sorry, but the provided text does not contain detailed information about acceptance criteria, study methodologies, or performance data for the Calcitonin Immunoradiometric Assay (IRMA) (Coated Tube Version).

The document is an FDA 510(k) clearance letter, which primarily confirms that the device is substantially equivalent to a legally marketed predicate device. It states the indications for use but does not delve into the specifics of performance studies, sample sizes, ground truth establishment, or expert qualifications that would be required to answer your detailed questions about acceptance criteria and how they were met.

Therefore, I cannot provide the requested table or the specific details regarding the studies performed.

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K Number

K990073

Device Name

CALCITONIN

Manufacturer

KMI DIAGNOSTICS, INC.

Date Cleared

1999-05-11

(120 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

The IBL Calcitonin Enzyme Immunoassay Kit provides materials intended to measure the thyroid calcitonin levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism. This assay is intended for in vitro diagnostic use only.

Device Description

Calcitonin ELISA Test Kit

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a Calcitonin ELISA Test Kit. It does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study from the provided input.

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