FDA.reportPublic FDA data

CLEVELAND DIAGNOSTICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30110153353011015335CLEVELAND DIAGNOSTICS, INC.1N2026-01-013615 Superior Ave Ste 4406a Cleveland OH US 44114

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860012266708IsoPSA Reagent - The IsoPSA® Reagent is part of the IsoPSA Assay, an in vitro diagnostic test system that combines the results of total prostate specific antigen (PSA) and free PSA from partitioned heparinized plasma into a single numerical index. The IsoPSA reagent vial contains a ready-to-use proprietary mixture of polymers and salts that forms an aqueous two-phase (biphasic) system. This system separates PSA structural variants based on their physicochemical properties.In the IsoPSA Assay workflow, a plasma sample is added to the IsoPSA reagent vial, mixed, and centrifuged to partition PSA isoforms into two distinct phases. An aliquot of the top-phase fraction is removed and analyzed along with the native plasma sample using an immunoanalyzer to quantify total PSA and free PSA. These measurements are used to calculate the IsoPSA Index.The IsoPSA Reagent is intended for use only with IsoPSA Assay components, including IsoPSA Controls, a dedicated centrifuge-mixer device, and Roche Elecsys total PSA and free PSA assays on a compatible immunoanalyzer. The reagent is provided ready to use and is for in vitro diagnostic use.18332656647customersupport@clevelanddx.com
00860012266715IsoPSA Controls - 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.18332656647customersupport@clevelanddx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3489231376428165P200048IsoPSA AssayQRF2025-11-28

GUDID#

IsoPSA Reagent - The IsoPSA® Reagent is part of the IsoPSA Assay, an in vitro diagnostic test system that combines the results of total prostate specific antigen (PSA) and free PSA from partitioned heparinized plasma into a single numerical index. The IsoPSA reagent vial contains a ready-to-use proprietary mixture of polymers and salts that forms an aqueous two-phase (biphasic) system. This system separates PSA structural variants based on their physicochemical properties.In the IsoPSA Assay workflow, a plasma sample is added to the IsoPSA reagent vial, mixed, and centrifuged to partition PSA isoforms into two distinct phases. An aliquot of the top-phase fraction is removed and analyzed along with the native plasma sample using an immunoanalyzer to quantify total PSA and free PSA. These measurements are used to calculate the IsoPSA Index.The IsoPSA Reagent is intended for use only with IsoPSA Assay components, including IsoPSA Controls, a dedicated centrifuge-mixer device, and Roche Elecsys total PSA and free PSA assays on a compatible immunoanalyzer. The reagent is provided ready to use and is for in vitro diagnostic use.

Cleveland Diagnostics, Inc.

2026-04-14

IsoPSA Controls - 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.

Cleveland Diagnostics, Inc.

2026-04-14