IsoPSA Controls
Basic Information
- Brand Name
- IsoPSA Controls
- Primary DI
- 00860012266715
- Version / Model
- P901
- Catalog Number
- P901
- Company Name
- Cleveland Diagnostics, Inc.
- Labeler DUNS
- 080629312
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-14
- Public Version
- 1
- Public Version Date
- 2026-04-22
- Public Version Status
- New
- Public Device Record Key
- 6a484de3-4610-4bbd-a2d6-9ec67ec68369
Device Description
The IsoPSA® Controls are in vitro diagnostic quality control materials intended for use with the IsoPSA Assay. The control set consists of two levels of control material designed to monitor the performance of the IsoPSA Assay across its reportable range. Each control level contains human serum-based material with assigned IsoPSA Index values. The IsoPSA Controls are processed in the same manner as patient samples, including mixing with IsoPSA Reagent, centrifugation to form a biphasic system, and subsequent measurement of total prostate specific antigen (PSA) and free PSA using a compatible immunoanalyzer. The measured values are used to verify that the IsoPSA Assay is performing within established specifications. The IsoPSA Controls are intended for use only with IsoPSA Assay components, including IsoPSA Reagent, a dedicated centrifuge-mixer device, and Roche Elecsys total PSA and free PSA assays. The controls are provided for in vitro diagnostic use and are not intended for use as calibrators.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QRF | Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52861 | Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860012266715 | GS1 |
Customer Contacts
- Phone
- 18332656647
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P200048 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius