Radioimmunoassay, C-Peptides Of Proinsulin
This device is a radioimmunoassay system used to measure C-peptide, a cleavage product of proinsulin, in patient specimens, providing an indirect measure of endogenous insulin secretion used in differentiating type 1 from type 2 diabetes and evaluating residual beta-cell function. It is classified as FDA Class 1, subject only to general controls with no premarket submission required. The product code is JKD, regulated under 21 CFR 862.1135, and assigned to the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JKD
- Device Class
- FDA class 1
- Regulation Number
- 862.1135
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K951848 | AIA-PACK CPR ASSAY | Feb 13, 1996 | Substantially Equivalent | Tosoh Medics, Inc. |
| K943767 | IMMULITE C-PEPTIDE | Mar 23, 1995 | Substantially Equivalent | Diagnostic Products Corp. |
| K896420 | DSL C-PEPTIDE RIA (DSL #7000) | May 24, 1990 | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. |
| K854066 | DOUBLE ANTIBODY C-PEPTIDE RIA KIT | Nov 12, 1985 | Substantially Equivalent | Diagnostic Products Corp. |
| K842267 | C-PEP-RIA-100 | Sep 06, 1984 | Substantially Equivalent | Institut National Des Radioelements |
| K833396 | C-PEPTIDE RADIOIMMUNOASSAY TEST KIT | Apr 13, 1984 | Substantially Equivalent | Serono Diagnostics, Inc. |
| K820666 | HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. | Jul 13, 1982 | Substantially Equivalent | Immuno Nuclear Corp. |
| K812689 | RIA QUANT C-PEPTIDE KIT | Oct 06, 1981 | Substantially Equivalent | Mallinckrodt Critical Care |
| K812288 | HUMAN C-PEPTIDE REAGENTS | Aug 31, 1981 | Substantially Equivalent | Immunex Radiochemical Diagnostics |
| K810718 | C-PEPTICE REAGENTS | Mar 31, 1981 | Substantially Equivalent | Calbiochem-Behring Corp. |
FEI Numbers
This FDA classification entry is associated with 36 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 36 registration numbers. Click on an entry to view related FDA registrations.