Search Results
Found 2 results
510(k) Data Aggregation
K Number
K970302Device Name
APO-TEK LP(A)
Manufacturer
PERIMMUNE, INC.
Date Cleared
1997-11-10
(287 days)
Product Code
DFC
Regulation Number
866.5600Why did this record match?
Applicant Name (Manufacturer) :
PERIMMUNE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Apo-Tek Lp(a)™ is an Apo(a) isoform independent enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma. The measurement of Lp(a), in conjunction with other lipoprotein tests, is of diagnostic significance when assessing atherosclerotic cardiovascular disease in specific populations.
Device Description
Apo-Tek Lp(a)™ is an apolipoprotein(a) [Apo(a)] isoform independent in vitro diagnostic enzyme-linked immunosorbent assay (ELISA) intended for the quantitiative assessment of lipoprotein(a) [Lp(a)] in human serum or plasma. This test utilizes a sandwich ELISA format in which the Lp(a) particle is captured with a specific anti-Apo(a) monoclonal antibody and, after washing away nonbound serum or plasma components, is detected with a peroxidase conjugated anti-apolipoprotein B [Apo B] polyclonal antibody.
Ask a Question
K Number
K970353Device Name
AURA TEK FDP
Manufacturer
PERIMMUNE, INC.
Date Cleared
1997-04-30
(90 days)
Product Code
MMW
Regulation Number
866.6010Why did this record match?
Applicant Name (Manufacturer) :
PERIMMUNE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AuraTek FDP is a rapid one-step gold dye particle lateral flow immunoassay indicated for the in vitro qualitative measurement of fibringen and fibrinogen degradation products (FDP) in human urine, to be used with standard cystoscopic examination to aid in the management of patients with a history of bladder cancer.
Device Description
AuraTek FDP is a one-step gold dye particle immunoassay on a porous carrier. Mobile purple-red dye particles labeled with anti-FDP and fibrinogen antibody and immobile capture anti-FDP and fibringgen antibodies are coated as discrete zones on the porous carrier. In addition a test control zone with antimurine IgG (Reaction Control 2) is coated on the carrier. A sample placed on the device is absorbed by the porous carrier. The rehydrated colored sol particles move through the porous carrier to the capture anti-FDP and then to the anti-murine IgG. If the sample contains FDP and/or fibrinogen, the antibodylabeled sol particles will bind in a sandwich-type reaction to the capture anti-FDP and fibrinogen antibody producing a purple-red dot in the test result window. With a negative sample, the white test result window remains unchanged at the time of reading. AuraTek FDP has the unique feature that the test run validity is double-checked with the appearance and disappearance of color in the Reaction Control 1 window and development of a purple-red dot in the Reaction Control 2 window.
Ask a Question
Page 1 of 1