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510(k) Data Aggregation
(34 days)
SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette
SAFECARE Fentanyl Urine Test Cassette is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of fentanyl in human urine at the cutoff concentrations of 1 ng/mL. 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 or LC/MS is the preferred confirmatory method. The test is intended for over-the-counter use and for in vitro diagnostic use only.
The SAFECARE Fentanyl Urine Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each SAFECARE Fentanyl Urine Test device consists of a Test Cassette, a Dropper and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.
Here's a breakdown of the acceptance criteria and the study details for the SAFECARE Fentanyl Urine Test Cassette, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" percentages (e.g., "must achieve X% sensitivity"). Instead, it presents performance data that implies the device met sufficient standards for clearance. The "performance" column below summarizes the key findings.
| Category | Description of Performance (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Precision | Demonstrate consistent and accurate results across different concentrations relative to the cutoff, ideally showing 100% agreement for concentrations significantly below or above the cutoff, and a mix around the cutoff. | Lot 1: 100% negative for -100%, -75%, -50% cutoff; 98% negative (1 positive) for -25% cutoff; 52% positive/48% negative for cutoff; 100% positive for +25%, +50%, +75%, +100% cutoff. |
| Lot 2: 100% negative for -100%, -75%, -50% cutoff; 98% negative (1 positive) for -25% cutoff; 50% positive/50% negative for cutoff; 100% positive for +25%, +50%, +75%, +100% cutoff. | ||
| Lot 3: 100% negative for -100%, -75%, -50% cutoff; 96% negative (2 positive) for -25% cutoff; 54% positive/46% negative for cutoff; 100% positive for +25%, +50%, +75%, +100% cutoff. | ||
| Stability | Device must remain functional and accurate for a specified shelf life under defined storage conditions. | Devices are stable for 24 months at 36-86°F based on accelerated stability studies. |
| Interference | No interference from a list of common physiological, pathological, or drug substances at specified concentrations when fentanyl is absent or at known concentrations (50% below/above cutoff). | No interference observed from a comprehensive list of compounds (e.g., Acetaminophen, Albumin, Glucose, Ibuprofen, Nicotine) at 100µg/mL or specified concentrations when fentanyl was at ±50% cutoff levels. |
| Specificity (Cross-Reactivity) | Minimal to no cross-reactivity with structurally similar compounds or other common opioids/drugs, especially for compounds listed as "no cross-reactivity." For fentanyl analogs, a defined cross-reactivity profile. | Detected various fentanyl analogs with varying cross-reactivity percentages (e.g., Acetyl fentanyl: 100%, Ocfentanil: 40%). Showed no cross-reactivity for a list of over 30 opioid compounds (e.g., Codeine, Morphine, Buprenorphine) tested at 100 µg/mL. |
| Effect of Urine Specific Gravity & pH | Device performance should not be significantly affected by variations in urine specific gravity (1.000-1.035) or pH (4-9) at critical fentanyl concentrations (50% below and 50% above cutoff). | All results were positive for samples at and above +50% Cut-Off and all negative for samples at and below -50% Cut-Off, regardless of specific gravity or pH within the tested ranges. |
| Method Comparison (Clinical Samples) | Demonstrated agreement with a confirmatory method (LC/MS) for both negative and positive clinical urine samples across a range of fentanyl concentrations, including those near the cutoff. A low number of discordant results is expected, especially near the cutoff. | Operator 1: |
- 39/40 (97.5%) agreement for Negative/Low Negative/Near Cutoff Negative.
- 38/40 (95%) agreement for Near Cutoff Positive/High Positive.
- Discordant (1 positive at 0.985 ng/mL LC/MS; 2 negative at 1.055 and 1.097 ng/mL LC/MS).
Operator 2: - 40/40 (100%) agreement for Negative/Low Negative/Near Cutoff Negative.
- 39/40 (97.5%) agreement for Near Cutoff Positive/High Positive.
- Discordant (2 positive at 0.954 and 0.993 ng/mL LC/MS; 1 negative at 1.055 ng/mL LC/MS).
Operator 3: - 40/40 (100%) agreement for Negative/Low Negative/Near Cutoff Negative.
- 39/40 (97.5%) agreement for Near Cutoff Positive/High Positive.
- Discordant (2 positive at 0.980 and 0.985 ng/mL LC/MS; 1 negative at 1.055 ng/mL LC/MS). |
| Lay-User Study | High percentage of correct results by lay users when following instructions, particularly for concentrations clearly below or above the cutoff. User instructions should be easily understood. | Correct result percentages: 100% for -100%, -75%, -50% cutoff; 95% for -25% cutoff; 100% for +25%, +50%, +75% cutoff. All lay users indicated instructions were easily followed. Flesch-Kincaid score indicated reading grade level
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