FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Calcium Reagent is intended for the quantitative determination of serum calcium using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of hyperparathyroidism, hypoparathyroidism, multiple myeloma, nephrosis, nephritis, pancreatitis and hypervitaminosis D.

Device Description

Calcium Reagent

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a Calcium Reagent device. It does not contain the information requested about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

This document is a regulatory approval letter, explicitly stating "We have reviewed your Section 510(k) notification...and we have determined the device is substantially equivalent...You may, therefore, market the device..." It confirms the device's classification, product code, and indications for use.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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K Number

K955939

Device Name

CALCIUM REAGENT

Manufacturer

DERMA MEDIA LAB., INC.

Date Cleared

1996-03-13

(83 days)

Product Code