Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1145](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1145) → CIA — Methylthymol Blue, Calcium

# CIA · Methylthymol Blue, Calcium

_Clinical Chemistry · 21 CFR 862.1145 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIA

## Overview

- **Product Code:** CIA
- **Device Name:** Methylthymol Blue, Calcium
- **Regulation:** [21 CFR 862.1145](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1145)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## 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).

## Classification Rationale

Class II.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K870369](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIA/K870369.md) | CALCIUM REAGENT-METHYL THYMOL BLUE METHOD | Trace Scientific , Ltd. | Aug 19, 1987 | SESE |
| [K863059](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIA/K863059.md) | CALCIOMETER | J. D. Assoc. | Sep 26, 1986 | SESE |
| [K822898](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIA/K822898.md) | DSL 1600 | Diagnostic Systems Laboratories, Inc. | Dec 9, 1982 | SESE |
| [K792396](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIA/K792396.md) | ELVI CALCIUM | Volu Sol Medical Industries | Dec 6, 1979 | SESE |
| [K771468](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIA/K771468.md) | MULTISTAT III CALCIUM TEST | Instrumentation Laboratory CO | Sep 12, 1977 | SESE |

## Top Applicants

- Diagnostic Systems Laboratories, Inc. — 1 clearance
- Instrumentation Laboratory CO — 1 clearance
- J. D. Assoc. — 1 clearance
- Trace Scientific , Ltd. — 1 clearance
- Volu Sol Medical Industries — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIA](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIA)

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