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 862.1390](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1390) → CDA — Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin

# CDA · Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin

_Clinical Chemistry · 21 CFR 862.1390 · Class 1_

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

## Overview

- **Product Code:** CDA
- **Device Name:** Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
- **Regulation:** [21 CFR 862.1390](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1390)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A 5-hydroxyindole acetic acid/serotonin test system is a device intended to measure 5-hydroxyindole acetic acid/serotonin in urine. Measurements of 5-hydroxyindole acetic acid/serotonin are used in the diagnosis and treatment of carcinoid tumors of endocrine tissue.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K952817](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDA/K952817.md) | BIO-RAD URINARY 5-HIAA BY HPLC | Bio-Rad | Aug 1, 1995 | SESE |
| [K903609](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDA/K903609.md) | SEROTONIN ENZYME IMMUNOASSAY | Immunotech Corp. | Oct 22, 1990 | SESE |
| [K854946](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDA/K854946.md) | TDXR 5-HIAA (URINE) | Abbott Laboratories | Jan 17, 1986 | SESE |

## Top Applicants

- Abbott Laboratories — 1 clearance
- Bio-Rad — 1 clearance
- Immunotech Corp. — 1 clearance

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

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