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 862.1380](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1380) → JKF — Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge

# JKF · Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge

_Clinical Chemistry · 21 CFR 862.1380 · Class 1_

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

## Overview

- **Product Code:** JKF
- **Device Name:** Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge
- **Regulation:** [21 CFR 862.1380](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1380)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A hydroxybutyric dehydrogenase test system is a device intended to measure the activity of the enzyme alpha-hydroxybutric dehydrogenase (HBD) in plasma or serum. HBD measurements are used in the diagnosis and treatment of myocardial infarction, renal damage (such as rejection of transplants), certain hematological diseases (such as acute leukemias and megaloblastic anemias) and, to a lesser degree, liver disease.

## 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 the limitations in § 862.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K861855](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKF/K861855.md) | HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET | Sterling Diagnostics, Inc. | Jun 16, 1986 | SESE |
| [K834084](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKF/K834084.md) | HYDROXYBUTYRATE DEHYDROGENASE REAGENT | Sterling Biochemical, Inc. | Feb 4, 1984 | SESE |

## Top Applicants

- Sterling Biochemical, Inc. — 1 clearance
- Sterling Diagnostics, Inc. — 1 clearance

---

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

**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