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 862.1135](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1135) → JKD — Radioimmunoassay, C-Peptides Of Proinsulin

# JKD · Radioimmunoassay, C-Peptides Of Proinsulin

_Clinical Chemistry · 21 CFR 862.1135 · Class 1_

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

## Overview

- **Product Code:** JKD
- **Device Name:** Radioimmunoassay, C-Peptides Of Proinsulin
- **Regulation:** [21 CFR 862.1135](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1135)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A C-peptides of proinsulin test system is a device intended to measure C-peptides of proinsulin levels in serum, plasma, and urine. Measurements of C-peptides of proinsulin are used in the diagnosis and treatment of patients with abnormal insulin secretion, including diabetes mellitus.

## 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 (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K951848](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKD/K951848.md) | AIA-PACK CPR ASSAY | Tosoh Medics, Inc. | Feb 13, 1996 | SESE |
| [K943767](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKD/K943767.md) | IMMULITE C-PEPTIDE | Diagnostic Products Corp. | Mar 23, 1995 | SESE |
| [K896420](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKD/K896420.md) | DSL C-PEPTIDE RIA (DSL #7000) | Diagnostic Systems Laboratories, Inc. | May 24, 1990 | SESE |
| [K854066](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKD/K854066.md) | DOUBLE ANTIBODY C-PEPTIDE RIA KIT | Diagnostic Products Corp. | Nov 12, 1985 | SESE |
| [K842267](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKD/K842267.md) | C-PEP-RIA-100 | Institut National Des Radioelements | Sep 6, 1984 | SESE |
| [K833396](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKD/K833396.md) | C-PEPTIDE RADIOIMMUNOASSAY TEST KIT | Serono Diagnostics, Inc. | Apr 13, 1984 | SESE |
| [K820666](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKD/K820666.md) | HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. | Immuno Nuclear Corp. | Jul 13, 1982 | SESE |
| [K812689](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKD/K812689.md) | RIA QUANT C-PEPTIDE KIT | Mallinckrodt Critical Care | Oct 6, 1981 | SESE |
| [K812288](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKD/K812288.md) | HUMAN C-PEPTIDE REAGENTS | Immunex Radiochemical Diagnostics | Aug 31, 1981 | SESE |
| [K810718](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKD/K810718.md) | C-PEPTICE REAGENTS | Calbiochem-Behring Corp. | Mar 31, 1981 | SESE |

## Top Applicants

- Diagnostic Products Corp. — 2 clearances
- Calbiochem-Behring Corp. — 1 clearance
- Diagnostic Systems Laboratories, Inc. — 1 clearance
- Immunex Radiochemical Diagnostics — 1 clearance
- Immuno Nuclear Corp. — 1 clearance

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

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