BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02

• K Number: K991111
• Device Name: BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02
• Manufacturer: A.P. TOTAL CARE, INC.
• Date Cleared: 1999-05-25 ( 54 days)
• Product Code: CIC
• Regulation Number: 862.1145
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

The calcium reagents: Buffer/Chromogen(R1), product No. CA110-01 and EDTA Reagent (R2), product No. CA110-02 are intended for Invitro Diagnostic use in the automated, quantitative determination of calcium in serum, plasma and urine.

Device Description

Buffer Chromogen (R1), EDTA Reagent (R2)

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a 510(k) clearance letter from the FDA for a device named "Buffer Chromogen (R1), EDTA Reagent (R2)" for the quantitative determination of calcium. It primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities. It does not contain a study report or details of performance testing.

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.