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 862.1240](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1240) → JLC — Nitroprusside Reaction (Qualitative, Urine), Cystine

# JLC · Nitroprusside Reaction (Qualitative, Urine), Cystine

_Clinical Chemistry · 21 CFR 862.1240 · Class 1_

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

## Overview

- **Product Code:** JLC
- **Device Name:** Nitroprusside Reaction (Qualitative, Urine), Cystine
- **Regulation:** [21 CFR 862.1240](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1240)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A cystine test system is a device intended to measure the amino acid cystine in urine. Cystine measurements are used in the diagnosis of cystinuria (occurrence of cystine in urine). Patients with cystinuria frequently develop kidney calculi (stones).

## 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K843382](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLC/K843382.md) | UROCYSTIN | Mission Pharmacal Co. | Jan 8, 1985 | SESE |
| [K810514](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLC/K810514.md) | SANDARE NITROPRUSSIDE TEST PROCEDURE | Sandare Chemical Co., Inc. | Mar 4, 1981 | SESE |

## Top Applicants

- Mission Pharmacal Co. — 1 clearance
- Sandare Chemical Co., Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com