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510(k) Data Aggregation
K Number
K993945Device Name
BIONIKE AQ PHENCYCLIDINE (PCP) TEST
Manufacturer
BIONIKE LABORATORIES, INC.
Date Cleared
1999-12-07
(18 days)
Product Code
LCM
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BIONIKE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bionike's AQ™ Phencyclidine (PCP) assay is a rapid, qualitative, competitive binding immunoassay for the determination of Phencyclidine (PCP) in urine at the cutoff level of 25 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated". Bionike Laboratories' AQ™ Phencyclidine (PCP) Test is not intended to monitor drug levels, but only to screen urines for the presence of Phencyclidine (PCP) and its metabolites.
Device Description
Bionike Laboratories' AQ™ Phencyclidine (PCP) Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 25 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.
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K Number
K972384Device Name
AQ ONE STEP COCAINE TEST
Manufacturer
BIONIKE LABORATORIES, INC.
Date Cleared
1997-08-06
(41 days)
Product Code
DIO
Regulation Number
862.3250Why did this record match?
Applicant Name (Manufacturer) :
BIONIKE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bionike One Step Cocaine Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of benzoylecgonine at a cutoff concentration of 300ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only.
Device Description
Not Found
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K Number
K971841Device Name
BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST
Manufacturer
BIONIKE LABORATORIES, INC.
Date Cleared
1997-06-25
(37 days)
Product Code
LDJ
Regulation Number
862.3870Why did this record match?
Applicant Name (Manufacturer) :
BIONIKE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bionike AQ™ One Step Cannabinoids Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of Cannabinoids and its metabolites at a cutoff concentration of 50ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only.
Device Description
Not Found
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K Number
K971361Device Name
AQ OPIATES (MORPHINE) TEST
Manufacturer
BIONIKE LABORATORIES, INC.
Date Cleared
1997-06-06
(56 days)
Product Code
DJG
Regulation Number
862.3650Why did this record match?
Applicant Name (Manufacturer) :
BIONIKE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bionike One Step Opiate(Morphine) Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of morphine and its metabolites at a cutoff concentration of 300ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only.
Device Description
Not Found
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K Number
K960992Device Name
BIONIKE A/Q PREGNANCY TEST
Manufacturer
BIONIKE LABORATORIES, INC.
Date Cleared
1996-04-25
(44 days)
Product Code
JHI
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
BIONIKE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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