(75 days)
The AssureTech Buprenorphine Strip test is an immunochromatographic assay for the qualitative determination of Buprenorphine in human urine at a Cut-Off concentration of 10ng/mL. This test is calibrated to Buprenorphine (calibrator). The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use.
The AssureTech Methadone Strip test is an immunochromatographic assay for the qualitative determination of Methadone in human urine at a Cut-Off concentration of 300ng/mL. This test is calibrated to Methadone (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use.
The AssureTech Buprenorphine/Methadone Panel Dip test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators). The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
The AssureTech Buprenorphine/Methadone Quick Cup test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL, and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators). The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
The AssureTech BuprenorphineMethadone Turn Key-Split Cup test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators). The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
The AssureTech Bunrenorphine Strip, AssureTech Methadone Strip, AssureTech Buprenorphine/Methadone Panel Dip, AssureTech Buprenorphine/Methadone Quick Cup and AssureTech Buprenorphine/Methadone Turn Key-Split Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Buprenorphine and/or Methadone (target analytes) in human urine. The Quick Cup format does not contain a turn-key for device activation. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
The provided document is a 510(k) Premarket Notification for in vitro diagnostic devices designed to detect Buprenorphine and Methadone in human urine. It details the performance characteristics of these devices.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria (Implicit) and Reported Device Performance
The acceptance criteria are generally implied by the performance goals set for the device, particularly regarding concordance with GC/MS results and successful performance across various drug concentrations. The precision studies and comparison studies demonstrate the device's performance against these implicit criteria.
Note: The document doesn't explicitly state numeric "acceptance criteria" for accuracy (e.g., "must achieve 90% positive agreement with GC/MS at +25% cutoff"). Instead, the data is presented, and the conclusion states that the performance characteristics are "acceptable." We can infer the acceptance criteria from the observed performance and the nature of qualitative drug tests.
Here is a summary of the reported device performance from the "Precision" and "Comparison Studies" sections:
Precision Studies (Table Summarization):
- Test Setup: Samples at -100%, -75%, -50%, -25%, +25%, +50%, +75%, +100% of the cut-off concentration. Confirmed by GC/MS. Blindly labeled. 2 runs per day for 25 days per device (total of 50 tests per concentration per lot). Three lots of each device were tested.
- Performance:
- Buprenorphine: For all device types (Strip, Panel Dip, Turn-Key Split Cup, Quick Cup) across three lots:
- All true negative concentrations (-100% to -25% cut-off) consistently yielded 50-/0+ (50 negative, 0 positive) results.
- All true positive concentrations (+25% to +100% cut-off) consistently yielded 50+/0- (50 positive, 0 negative) results.
- Results at the "cut off" (0% cut-off, which should be 10 ng/mL) showed some variability, as expected for qualitative tests around the threshold. For example, for Buprenorphine Strip, Lot 1 showed 4-/46+ (4 negative, 46 positive) at cut-off, while Lot 2 showed 1-/49+. This indicates the ability to correctly identify samples near the cutoff, with some expected variation around the 50/50 mark.
- Methadone: Similar trends were observed for Methadone across all device types and lots.
- All true negative concentrations (-100% to -25% cut-off) consistently yielded 50-/0+ results.
- All true positive concentrations (+25% to +100% cut-off) consistently yielded 50+/0- results.
- Results at the "cut off" (0% cut-off, 300 ng/mL) showed variability, e.g., Methadone Strip, Lot 1 showed 2-/48+.
- Buprenorphine: For all device types (Strip, Panel Dip, Turn-Key Split Cup, Quick Cup) across three lots:
Comparison Studies with GC/MS (Table Summarization using a general view as specific numerical acceptance criteria like sensitivity/specificity are not given, but concordance is key):
- Setup: In-house study with 80 unaltered clinical samples (40 negative, 40 positive) per drug per device type. Operators ran blind-labeled samples. GC/MS was the reference method. Each device type (Strip, Panel Dip, Turn-Key Split Cup, Quick Cup) was evaluated for both Buprenorphine and Methadone.
- General Performance (Across all device types for Buprenorphine and Methadone):
- Negative Samples: Consistently showed 10 Negative (from true negative GC/MS) and 20 Low Negative (GC/MS
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).