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510(k) Data Aggregation
K Number
K191099Device Name
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
Manufacturer
Atlas Medical
Date Cleared
2019-10-03
(161 days)
Product Code
DKZ, DIO, DIS, DJC, DJG, DJR, DNK, JXM, JXN, LCM, LDJ, LFG
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
Atlas Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Atlas Multi-Drugs Screening Test Cup and Atlas Multi-Drugs Screening Test Panel are lateral flow chromatographic in vitro diagnostics immunoassays for the qualitative detection of following drugs in urine without the need of instruments: Amphetamine (AMP), Methylenedioxymethamphetamine (MDMA), Morphine (MOP), Oxycodone (OXY), Cocaine (COC), Nortriptyline, Methamphetamine (MET), Phencyclidine (PCP), Marijuana (THC), Secobarbital, Oxazepam, Methadone (MTD), Propoxyphene (PPX), Buprenorphine(BUP). The tests are intended for professional use only. The tests will yield preliminary positive results when the prescription drugs Secobarbital, oxazepam, Buprenorphine, Oxycodone, Propoxyphene, and Nortriptyline are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital, oxazepam, Buprenorphine, Oxycodone, Propoxyphene, and Nortriptyline in urine. The multi-drugs screening tests (Cup and Panel formats) show the drug was or was not present at the cutoff level. The tests provide only preliminary test results, which must be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring the drug levels.
Device Description
Atlas Multi-Drugs Screening Test cup format is single use device. The user collects urine in the cup to the recommended volume. The reaction is initiated by movement the sample to the strip. The strips are incorporated into the sides of sample cup. Atlas Multi-Drugs Screening Test panel format is single use dip card device. The user inserts the absorbent end of the device in the urine sample to the maximum level indicated by the line on the device label. The test reaction is initiated by movement of the sample through the strip. Atlas Multi-Drugs Screening Tests (Cup and Panel Formats) detect up to 14 drugs.
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K Number
K102760Device Name
ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001
Manufacturer
ATLAS MEDICAL
Date Cleared
2011-08-03
(314 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
ATLAS MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Atlas Home Pregnancy Test (Midstream Format) is a home use (OTC) rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in the urine to aid in the early detection of pregnancy.
Device Description
Home Pregnancy Test (Midstream Format) is an OTC single use rapid Atlas chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
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