VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE

• K Number: K983790
• Device Name: VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE
• Manufacturer: SUN BIOMEDICAL LABORATORIES, INC.
• Date Cleared: 1999-03-01 ( 125 days)
• Product Code: LCM
• Regulation Number: N/A
• Type: Traditional
• Panel: TX
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Visualine® II Assay is used for qualitative testing for the presence of Phencyclidine in urine.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as requested. The document is a 510(k) clearance letter from the FDA for a device named "Visualine® II Phencyclidine (SunLine™ Phencyclidine)", indicating that it has been found substantially equivalent to a legally marketed predicate device.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance details.
3. Number or qualifications of experts used for establishing ground truth.
4. Adjudication methods.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size.
6. Details about a standalone algorithm performance study.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The letter primarily focuses on regulatory approval and classification, and refers to the "indications for use" without providing the underlying study data. The "Indications For Use" section states: "The Visualine® II Assay is used for qualitative testing for the presence of Phencyclidine in urine." This describes the device's function but not its performance metrics or the studies backing them.

Regulation Number and Section

N/A