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K Number
K121231
Device Name
IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST
Manufacturer
IND NDIAGNOSTIC INC.
Date Cleared
2012-07-30

(97 days)

Product Code
NGT,NFW,NFY,NGG,NGI
Regulation Number
880.5200
Type
Traditional
Panel
General Hospital
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The IND Drug Home Test is a rapid chromatographic immunoassay multi-panel or single drug test for the qualitative detection of one or more of the following drugs: Amphetamine, Methamphetamine, Cocaine, Marijuana, and Morphine in human urine. It is intended for overthe-counter use.

The test is intended for over-the counter (OTC) use as the first step in a two step process to provide consumers with information concerning the presence of the above stated drugs or metabolites in a urine sample. The test provides only preliminary test results. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. GC/MS (Gas Chromatography / Mass Spectrometry) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.

Device Description

Not Found

AI/ML Overview

The provided text describes the regulatory clearance of a drug testing device (IND Drug Home Multi-Panel Test) and does not contain detailed information about acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot extract the specific information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details from the given text.

The text primarily focuses on:

  • The FDA's determination of substantial equivalence for the device.
  • The regulatory classification and applicable regulations.
  • The intended use of the device (qualitative detection of specific drugs in human urine for over-the-counter use).
  • The cut-off levels for each drug.
  • The requirement for confirmatory testing (GC/MS).

To answer your questions, I would need a detailed study report or performance evaluation section for the IND Drug Home Multi-Panel Test.

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).