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) → JNO — N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin

# JNO · N-Benzoyl-L-Arginine Ethyl 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/JNO

## Overview

- **Product Code:** JNO
- **Device Name:** N-Benzoyl-L-Arginine Ethyl 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 (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K110274](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNO/K110274.md) | AUTODELFIA NEONATAL IRT KIT | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | Jun 10, 2011 | SESE |
| [K102419](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNO/K102419.md) | GSP NEONATAL IRT KIT (3306-001U) | Wallac Oy, Subsidiary of Perkinelmer | Dec 16, 2010 | SESE |
| [K932406](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNO/K932406.md) | NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT | Nuclear Diagnostics, Inc. | Dec 2, 1993 | SESE |
| [K883011](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNO/K883011.md) | MRI NEO-TRYP TRYPSIN RIA | Microbiological Research Corp. | Apr 26, 1989 | SESE |
| [K861097](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNO/K861097.md) | TRYPSIN RIA KIT | Microanalytic Research, Inc. | May 29, 1986 | SESE |
| [K811805](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNO/K811805.md) | TRYPIN (125I) RIA KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 31, 1981 | SESE |
| [K791202](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNO/K791202.md) | RIA KIT FOR TRYPSIN | Cis Radiopharmaceuticals, Inc. | Nov 5, 1979 | SESE |

## Top Applicants

- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Cis Radiopharmaceuticals, Inc. — 1 clearance
- Microanalytic Research, Inc. — 1 clearance
- Microbiological Research Corp. — 1 clearance
- Nuclear Diagnostics, Inc. — 1 clearance

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

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