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510(k) Data Aggregation
(174 days)
IMMULITE® Amphetamine is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE Automated Analyzer and designed for the qualitative measurement of Amphetamine in urine. It is intended strictly for in vitro diagnostic use in clinical laboratories, in the context of a program involving an established confirmatory test for amphetamine. A cutoff of 500 ng/mL is used by the IMMULITE Amphetamine assay to identify positive and negative results.
IMMULITE® Amphetamine is a solid-phase chemiluminescent enzyme immunoassay for use with the IMMULITE® Automated Analyzer.
Here's an analysis of the acceptance criteria and study detailed in the provided text for the IMMULITE® Amphetamine device:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state formal "acceptance criteria" in a quantitative manner (e.g., "sensitivity must be >X%"). Instead, the performance is reported as a comparison to two other methods, demonstrating substantial equivalence. The implied acceptance is that the device performs comparably to established methods for amphetamine detection in urine.
| Performance Metric | IMMULITE Amphetamine vs. DPC's Double Antibody Amphetamine (Predicate Device) | IMMULITE Amphetamine vs. GC/MS (Confirmatory Method) |
|---|---|---|
| Relative Sensitivity | 100% (Positive vs. Positive: 32/32) | Not explicitly reported as "relative sensitivity" but implied by 0 false negatives. |
| Relative Specificity | 98% (Negative vs. Negative: 125/128) | Not explicitly reported as "relative specificity" but implied by 4 false positives. |
| Agreement | 98% (Overall agreement: (32+125)/160) | Not explicitly reported. |
| False Positives | 3/128 (2.3% when DAb Amphetamine was negative) | 4/32 (12.5% when GC/MS was negative) |
| False Negatives | 0/32 (0% when DAb Amphetamine was positive) | 0/18 (0% when GC/MS was positive) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set 1 (vs. DPC's Double Antibody Amphetamine): 160 urine samples.
- Test Set 2 (vs. GC/MS): 50 urine samples.
- Data Provenance: The samples were obtained from "volunteer donors, presumed not to be drug abusers, and from a reference lab." This suggests a mix of potentially healthy individuals and samples that might represent a broader clinical spectrum. The study appears to be retrospective as these samples were collected and then analyzed with both methods. The country of origin is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
No direct mention of "experts" in the context of establishing ground truth. The ground truth for comparative studies was based on:
- The results of a predicate device (DPC's Double Antibody Amphetamine assay).
- The results of GC/MS (Gas Chromatography/Mass Spectrometry), which is typically considered a gold standard confirmatory method for drug testing but doesn't involve human 'experts' establishing a subjective ground truth.
4. Adjudication Method for the Test Set
Not applicable. The comparisons are against a predicate device and a confirmatory analytical method (GC/MS) rather than subjective expert interpretations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an in-vitro diagnostic (IVD) assay for chemical analysis, not an imaging or diagnostic device that involves human readers interpreting results with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this was a standalone performance study. The IMMULITE® Amphetamine assay is an automated, solid-phase chemiluminescent enzyme immunoassay. Its performance was evaluated purely on its analytical output compared to other analytical methods. The results generated by the device are quantitative (photon output) and then categorized as positive/negative based on a predefined cutoff of 500 ng/mL, making it an "algorithm only" type of performance without human interpretation as part of its primary function.
7. The Type of Ground Truth Used
- For comparison against the predicate device: The ground truth was the result from the DPC's Double Antibody Amphetamine assay. This is a comparator method, serving as a de facto "ground truth" for demonstrating substantial equivalence.
- For comparison against GC/MS: The ground truth was the result from GC/MS. This is a confirmatory analytical method, widely considered a "gold standard" for drug identification and quantification in toxicology.
8. The Sample Size for the Training Set
The document does not provide information about a "training set." This type of device (immunoassay) typically involves assay development and calibration rather than machine learning training in the conventional sense. The "Adjustor supplied with the kit" serves as a calibrator to define the 500 ng/mL cutoff for qualitative results.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no conventional "training set" with ground truth in the AI/ML sense is mentioned or implied for this type of immunoassay. The cutoff (500 ng/mL) is an established regulatory threshold for amphetamine screening. The "Adjustor" in the kit is used to set the cutoff, and its value would be determined during the assay's development and manufacturing quality control to align with the 500 ng/mL threshold.
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