AccessGUDID - DEVICE: REAADS Anti-Phosphatidylserine IgG/IgM Semi-Quantitative Test Kit (96 Well) (00855360006090)

GUDID

Device Identifier (DI) Information

Brand Name: REAADS Anti-Phosphatidylserine IgG/IgM Semi-Quantitative Test Kit (96 Well)
Version or Model: 030-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 030-001
Company Name: CORGENIX MEDICAL CORPORATION

Primary DI Number: 00855360006090
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 619834542 *Terms of Use

Device Description: INTENDED USE Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use. SUMMARY AND EXPLANATION OF THE ANTI-PHOSPHATIDYLSERINE TEST High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (i.e., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. These antibodies have been associated with an increased risk for recurrent arterial and venous thrombotic events, thrombocytopenia and fetal loss. Phosphatidylserine is a more physiologically relevant phospholipid due to its presence in cell membranes of endothelial cells and platelets. PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in phosphatidylserine coated microwells. β2-glycoprotein I is provided in the sample diluent. After the removal of unbound serum/plasma proteins by washing, antibodies specific for human IgG or IgM, labeled with horseradish peroxidase (HRP), are added forming complexes with the phosphatidylserine bound antibodies. Two enzyme-conjugated antibody solutions are provided, one specific for human IgG antibodies and one specific for human IgM antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-phosphatidylserine (aPS) antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided for both IgG and IgM antibody concentrations expressed in GPS or MPS units. Control and patient results are determined from the calibration curve. Refer to Package Insert.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
55082	Phosphatidylserine antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antiphosphatidylserine antibodies in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MID	System, Test, Anticardiolipin Immunological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 31c6b868-dda8-4d60-baa2-4d24b192982a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 14, 2016