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510(k) Data Aggregation
K Number
K050975Device Name
NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN
Manufacturer
NANO-DITECH CO.
Date Cleared
2006-03-02
(318 days)
Product Code
MMI, DDR, JHT
Regulation Number
862.1215Why did this record match?
Applicant Name (Manufacturer) :
NANO-DITECH CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nano-Check ™AMI 3 IN 1 Test is a rapid immunoassay for the qualitative determination of Cardiac Troponin I (cTnl), Creatine Kinase MB (CK-MB), and Myoglobin in human serum and plasma specimens at cutoff concentrations of 0.5 ng/ml, 5.0 ng/ml, and 80 ng/ml, respectively, as an aid in the diagnosis of Acute Myocardial Infarction (AMI).
The Nano-Check™ AMI 3 IN 1 Test is a qualitative assay, which can not monitor the rise and fall of cTnl, CK-MB, and Myoglobin in single testing. Single testing is not recommended for AMI monitoring. Test results should be interpreted by the physician in conjunction with other laboratory test results and patient clinical findings.
Device Description
The Nano-Check ™ AMI 3 IN 1 Test is a one-step lateral flow immunochromatography assay for the qualitative determination of three cardiac markers simultaneously in serum and heparin plasma.
The test is a single-use, visually read, cassette device in a plastic housing. Membrane strip inside the plastic housing contains immobilized molecules at three test lines and one control line; CK-MB antibody, Myoglobin antibody, streptavidine and goat anti-mouse antibody. Dye pad at the end of the membrane strip contains biotinylated cTnl antibody and gold colloidal particles coupled with CK-MM, cTnl and Myoqlobin antibodies. Cutoff level of each marker is 0.5 ng/ml, 5 ng/ml and 80 ng/ml for cTnl. CK-MB and Myoglobin respectively.
Device is sealed in pouch with desiccant and provided with instructions for use and disposable sample dropper.
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K Number
K050594Device Name
NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE
Manufacturer
NANO-DITECH CO.
Date Cleared
2005-05-15
(68 days)
Product Code
LDJ, DIO, DJC, DJG, LCM
Regulation Number
862.3870Why did this record match?
Applicant Name (Manufacturer) :
NANO-DITECH CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nano-Check™ DAT 5 Multi Drug Screening Test for Marijuana, Opiates, Cocaine, Methamphetamine and Phencyclidine is a rapid, self-controlled immunoassay for the qualitative detection of Cannabinoids (THC), Opiates (OPI), Benzoylecgonine (COC), Methamphetamine (mAMP) and Phencyclidine (PCP) compounds and their metabolites in human urine. The detection limits (cut-off concentrations) of this test are as follows: Cannabinoids at 50 ng/ml, Opiates at 2000 ng/ml, Cocaine at 300 ng/ml, Methamphetamine at 1000 ng/ml and Phencyclidine at 25 ng/ml. This assay is intended for Professional and Laboratory In-Vitro Use Only.
Device Description
The Nano-Check™ DAT 5M test is a one step, type II, competitive immuochromatographic assay for the qualitative detection of Cannabinoid, Opiate, Benzoylecgonine, Methamphetamine and Phencyclidine compounds and their metabolites in human urine. The Nano-Check™ DAT 5M test device contains a membrane strip on which either antibodies against drug or drug conjugate to protein are immobilized at each specific test line. The colored indicator antibody or antigen coupled with Gold colloidal particles is place at the end of membrane.
The test is a single-use visually read cassette device in a plastic housing. It contains the test strip containing 5 test lines and 1 control line. Urine sample can be dropped onto sample well using plastic disposable dropper, which is provided. Drug positive urines will not show a colored band, while drug negative urine sample or urine sample containing drugs below cutoff level will generate red colored band.
The device is sealed in a pouch desiccant and provided with instructions for use and a disposable sample dropper.
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