(90 days)
Healgen Propoxyphene Test is an immunochromatographic assay for the qualitative determination of Propoxyphene in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format.
The test may yield preliminary positive results even when the prescription drug Propoxyphene is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Propoxyphene 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. GC/MS is the prefered 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. It is intended for prescription and for over-the-counter use.
Healgen Nortriptyline Test is an immunochromatographic assay for the qualitative determination of Nortriptyline in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format.
The test may yield preliminary positive results even when the prescription is ingested, at prescribed doses, it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Nortriptyline 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. GC/MS is the prefered 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. It is intended for prescription and for over-the-counter use.
Healgen EDDP (Methadone Metabolite) Test is an immunochromatographic assay for the qualitative determination of EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS 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. It is intended for prescription and for over-the-counter use.
Healgen Propoxyphene Test, Healgen Nortriptyline Test and Healgen EDDP (Methadone Metabolite) Test are immunochromatographic assays for Propoxyphene, Nortriptyline and EDDP. Each assay test is a lateral flow system for the qualitative detection of Propoxyphene, Nortriptyline and EDDP (target analyte) in human urine. The products are in vitro diagnostic devices, which come in the form of: Strips, Cassettes, DipCards, or Cups. Each product contains a Test Device (in one of the four formats), and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.
The provided document describes the performance characteristics of the Healgen Propoxyphene Test, Healgen Nortriptyline Test, and Healgen EDDP (Methadone Metabolite) Test, which are immunochromatographic assays for the qualitative determination of these substances in human urine. The acceptance criteria and the studies performed to demonstrate the device meets these criteria are detailed.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a separate, quantified threshold for each performance characteristic. Instead, it presents the results of various analytical and comparison studies, implying that the observed performance meets the manufacturer's internal standards for claiming substantial equivalence to a predicate device. For the purpose of this response, I will interpret the reported performance in the precision and cut-off studies as the de facto acceptance criteria demonstrated by the manufacturer.
The key acceptance criterion for qualitative drug tests is typically the ability to correctly classify samples as positive or negative relative to a defined cut-off concentration. For samples precisely at or near the cut-off, some variability is expected.
Implicit Acceptance Criteria and Reported Performance (Based on "Precision" and "Cut-off" Studies):
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision | Consistent and accurate classification of samples at various concentrations around the cut-off, with expected variability at the exact cut-off. Ideally, 100% agreement for samples sufficiently below and above the cut-off. For samples at the cut-off, results should be approximately 50% positive and 50% negative. | Propoxyphene (All formats): Samples at -100%, -75%, -50%, -25% cut-off consistently yielded 50-/0+ (negative) results across all three lots for each format. Samples at +25%, +50%, +75%, +100% cut-off consistently yielded 50+/0- (positive) results across all three lots for each format. At the cut-off, results varied (e.g., Strip: 25-/25+, 21-/29+, 27-/23+; Cassette: 27-/23+, 22-/28+, 22-/28+; Dip Card: 26-/24+, 26-/24+, 23-/27+; Cup: 25-/25+, 21-/29+, 29-/21+). This indicates appropriate performance at and around the cut-off. |
| Nortriptyline (All formats): Samples at -100%, -75%, -50%, -25% cut-off consistently yielded 50-/0+ (negative) results. Samples at +25%, +50%, +75%, +100% cut-off consistently yielded 50+/0- (positive) results. At the cut-off, results varied (e.g., Strip: 20-/30+, 24-/26+, 21-/29+; Cassette: 20-/30+, 22-/28+, 18-/32+; Dip Card: 22-/28+, 26-/24+, 18-/32+; Cup: 26-/24+, 24-/26+, 21-/29+). This also indicates appropriate performance at and around the cut-off. | ||
| EDDP (All formats): Samples at -100%, -75%, -50%, -25% cut-off consistently yielded 50-/0+ (negative) results. Samples at +25%, +50%, +75%, +100% cut-off consistently yielded 50+/0- (positive) results. At the cut-off, results varied (e.g., Strip: 27-/23+, 23-/27+, 28-/22+; Cassette: 28-/22+, 20-/30+, 23-/27+; Dip Card: 21-/29+, 26-/24+, 22-/28+; Cup: 29-/21+, 24-/26+, 18-/32+). This demonstrates appropriate performance at and around the cut-off. | ||
| Cut-off Verification | 100% correct classification of samples at +/- 25% of the cut-off, within a specified margin of error. | For Propoxyphene, Nortriptyline, and EDDP, results were all positive at and above +25% cut-off and all negative at and below -25% cut-off. This confirms the accuracy of the stated cut-off values. |
| Interference | No significant interference from common exogenous or endogenous substances found in urine. | A comprehensive list of compounds (e.g., Acetophenetidin, Ascorbic Acid, Caffeine, etc.) showed no interference at a concentration of 100µg/mL in drug-free urine or urine spiked with target drugs at 25% above cut-off levels. This was consistent across all formats. |
| Specificity | Demonstrate cross-reactivity with structurally similar compounds and no significant cross-reactivity with unrelated analytes. | Propoxyphene: Positive at 300 ng/mL (100% cross-reactivity) for Propoxyphene and Norpropoxyphene (metabolite). |
| Nortriptyline: Positive at 1000 ng/mL (100% cross-reactivity) for Nortriptyline. Shows cross-reactivity with related tricyclic antidepressants (e.g., Amitriptyline 67%, Desipramine 20%, Imipramine 10%). | ||
| EDDP: Positive at 300 ng/mL (100% cross-reactivity) for EDDP. Cross-reactivity with EMDP (60%). No cross-reactivity with Methadone, LAAM, Alpha Methadol, Doxylamine at 100000 ng/mL ( |
§ 862.3910 Tricyclic antidepressant drugs test system.
(a)
Identification. A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.(b)
Classification. Class II (special controls). A tricyclic antidepressant drugs 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).