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 862.1070](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1070) → KHM — Nephelometric, Amylase

# KHM · Nephelometric, Amylase

_Clinical Chemistry · 21 CFR 862.1070 · Class 2_

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

## Overview

- **Product Code:** KHM
- **Device Name:** Nephelometric, Amylase
- **Regulation:** [21 CFR 862.1070](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1070)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## Identification

An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

## Classification Rationale

Class II.

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K831295](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHM/K831295.md) | AMYLASE REAGENT #88129 | Hi Chem, Inc. | Jun 30, 1983 | SESE |
| [K812699](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHM/K812699.md) | AMYLASE | Pointe Scientific, Inc., | Oct 6, 1981 | SESE |
| [K812447](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHM/K812447.md) | AMYLASE REAGENT KIT | Bioscientific | Sep 9, 1981 | SESE |
| [K801096](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHM/K801096.md) | PERKIN ELMER MODEL 91 AMYLASE REAGENT | Stat Engineering | Jun 9, 1980 | SESE |
| [K790797](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHM/K790797.md) | AMYLASE REAGENT SET | Alta Diagnostics, Inc. | Jul 17, 1979 | SESE |
| [K770400](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHM/K770400.md) | REAGENT, AMYLASE LIPASE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Apr 26, 1977 | SESE |

## Top Applicants

- Alta Diagnostics, Inc. — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Bioscientific — 1 clearance
- Hi Chem, Inc. — 1 clearance
- Pointe Scientific, Inc., — 1 clearance

---

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

**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