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 862.1725](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1725) → JNN — P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin

# JNN · P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin

_Clinical Chemistry · 21 CFR 862.1725 · Class 1_

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

## Overview

- **Product Code:** JNN
- **Device Name:** P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin
- **Regulation:** [21 CFR 862.1725](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1725)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A trypsin test system is a device intended to measure the activity of trypsin (a pancreatic enzyme important in digestion for the breakdown of proteins) in blood and other body fluids and in feces. Measurements obtained by this device are used in the diagnosis and treatment of pancreatic 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 § 862.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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