Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2500](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2500) → JJI — Analyzer, Enzyme, For Clinical Use

# JJI · Analyzer, Enzyme, For Clinical Use

_Clinical Chemistry · 21 CFR 862.2500 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJI

## Overview

- **Product Code:** JJI
- **Device Name:** Analyzer, Enzyme, For Clinical Use
- **Regulation:** [21 CFR 862.2500](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2500)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

An enzyme analyzer for clinical use is a device intended to measure enzymes in plasma or serum by nonkinetic or kinetic measurement of enzyme-catalyzed reactions. This device is used in conjunction with certain materials to measure a variety of enzymes as an aid in the diagnosis and treatment of certain enzyme-related disorders.

## 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 (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K972024](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJI/K972024.md) | CODA AUTOMATED EIA ANALYZER | Bio-Rad | Jul 30, 1997 | SESE |
| [K944731](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJI/K944731.md) | ABBOTT IMX 2 ANALYZER | Abbott Laboratories | Dec 19, 1994 | SESE |
| [K931970](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJI/K931970.md) | ABBOTT IMX2 ANALYER | Abbott Laboratories | Jun 16, 1993 | SESE |
| [K930898](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJI/K930898.md) | RADIAS AUTOMATED IMMUNOASSAY SYSTEM | Bio-Rad | Apr 21, 1993 | SESE |
| [K790073](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJI/K790073.md) | ANALYZER, IMPACT 100 | Gilford Instrument Laboratories, Inc. | Feb 22, 1979 | SESE |
| [K780972](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJI/K780972.md) | QUICKRATE REACTION RATE ANALYZER | Olympus Corp. | Aug 14, 1978 | SESE |
| [K771591](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJI/K771591.md) | MINISTAT-S CHEMISTRY ANALYZER | Biokinetix Corp. | Sep 20, 1977 | SESE |
| [K770401](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJI/K770401.md) | LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Apr 26, 1977 | SESE |

## Top Applicants

- Abbott Laboratories — 2 clearances
- Bio-Rad — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Biokinetix Corp. — 1 clearance
- Gilford Instrument Laboratories, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJI](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJI)

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