(121 days)
For in vitro diagnostic use only. VITROS Chemistry Products PCP Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of phencyclidine (PCP) in human urine using a cutoff of 25 ng/mL. Measurements obtained with the VITROS PCP method are used in the diagnosis and treatment of phencyclidine use or overdose.
The VITROS Chemistry Products PCP assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when evaluating a preliminary positive result.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 26 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of drugs of abuse.
For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS Chemistry Systems.
For in vitro diagnostic use only. VITROS Chemistry Products DAT Performance Verifiers are assayed controls used to monitor performance of urine drugs of abuse screening assays on VITROS 5,1 FS Chemistry Systems.
The VITROS PCP assay is a homogeneous enzyme immunoassay that is performed using the VITROS Chemistry Products PCP Reagent with the VITROS Chemistry Products Calibrator Kit 26, VITROS Chemistry Products FS Calibrator 1 and VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent / DAT Diluent 2) on VITROS 5,1 FS Chemistry Systems. The VITROS PCP Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect phencyclidine in urine. Samples, calibrators, and controls are automatically treated with surfactant (DAT Diluent 2) prior to addition of reagents. Treated sample is added to Reagent 1 containing antibody reactive to phencyclidine, glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD), followed by Reagent 2 containing phencyclidine labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH). The assay is based on competition between phencyclidine in the treated urine sample and phencyclidine labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, therefore the concentration of phencyclidine in the urine sample is directly proportional to measured enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically at 340 nm. VITROS Chemistry Products Calibrator Kit 26 is prepared from human urine to which drugs of abuse, metabolites of drugs of abuse, organic salt, surfactants, and preservative have been added. VITROS FS Calibrator 1 is prepared from sodium chloride and processed water. VITROS Calibrator Kit 26 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5.1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of phencyclidine (PCP). VITROS Chemistry Products DAT Performance Verifiers I. II, and V are prepared from a human urine pool to which analytes, surfactant, and preservative have been added. These are assaved controls used to monitor performance of the VITROS PCP assay on VITROS 5,1 FS Chemistry Systems. The VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent/ DAT Diluent 2) is a common reagent that is used with several drugs of abuse assays to dilute calibrators and samples on the VITROS 5,1 FS System. This is a dual chambered package containing two ready-to-use liquid diluents. DAT Diluent is prepared from human urine to which organic salt, surfactants, and preservative have been added. DAT Diluent 2 is prepared from processed water to which surfactant and preservative have been added. The VITROS 5,1 FS Chemistry System is a clinical chemistry instrument that provides automated use of the VITROS Chemistry Products MicroTip® and MicroSlides® range of products. The VITROS 5,1 FS System was cleared for market by 510(k) premarket notification (K031924).
This document describes the VITROS Chemistry Products PCP Reagent, VITROS Chemistry Products Calibrator Kit 26, VITROS Chemistry Products FS Calibrator 1, and VITROS Chemistry Products DAT Performance Verifiers, which are devices used for the semi-quantitative or qualitative determination of phencyclidine (PCP) in human urine.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" as a separate section with specific numerical targets. Instead, it demonstrates the device's performance through comparison with legally marketed predicate devices. The primary acceptance criterion implicit in the 510(k) submission process is substantial equivalence to the predicate device.
The study aimed to show good agreement between the VITROS PCP assay and the predicate device (DADE BEHRING Syva® EMIT® II Plus Phencyclidine Assay).
| Device Characteristic | VITROS PCP Assay (New Device) Performance | Predicate Device (Syva® EMIT® II Plus Phencyclidine Assay) Performance | Acceptance Criteria (Implicit) |
|---|---|---|---|
| Intended Use | Qualitative and semi-quantitative analysis of phencyclidine in human urine. | Qualitative and semi-quantitative analysis of phencyclidine in human urine. | Substantially equivalent intended use. |
| Cut-Off Value | 25 ng/mL | 25 ng/mL | Match predicate device's cut-off value. |
| Sample Type | Human Urine | Human Urine | Match predicate device's sample type. |
| Reagent Format | Liquid ready to use | Liquid ready to use | Match predicate device's reagent format. |
| Antibody Source | Sheep polyclonal antibodies reactive to phencyclidine. | Sheep polyclonal antibodies reactive to phencyclidine. | Match predicate device's antibody source. |
| Calibration Traceability | Phencyclidine with confirmation by GC/MS | Phencyclidine with confirmation by GC/MS | Match predicate device's calibration traceability. |
| Calibrator Matrix | Human urine | Human urine | Match predicate device's calibrator matrix. |
| Control Matrix | Human urine | Human urine | Match predicate device's control matrix. |
| Agreement | "demonstrated good agreement" | N/A (predicate performance is the benchmark) | "Good agreement" with the predicate immunoassay method. |
| Reportable Range | 6.0 - 72.0 ng/mL | 8 - 90 ng/mL | Similar but not identical. The difference is acknowledged and implicitly acceptable for substantial equivalence. |
| Calibrator: Number of levels | Five | Qualitative: Three; Semi-quantitative: Five | Similar, with a consistent number for semi-quantitative use. |
| Calibrator Format | Frozen Liquid ready to use | Refrigerated liquid ready to use | Difference acknowledged and implicitly acceptable for substantial equivalence. |
| Instrumentation | VITROS 5,1 FS Chemistry Systems | Multiple automated clinical chemistry systems | Difference acknowledged and implicitly acceptable for substantial equivalence. |
| Control Claimed Analytes | More specific list focusing on PCP detection. | Broader list including more substances. | Difference acknowledged and implicitly acceptable for substantial equivalence, as the primary analyte (PCP) is consistent. |
| Control: Number of Levels | Three | Two | Difference acknowledged and implicitly acceptable for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "Equivalence to the predicates was demonstrated using a commercially available assay along with patient samples."
- Test Set Sample Size: The exact number of "patient samples" used is not specified in the provided text.
- Data Provenance: The document does not explicitly state the country of origin. The use of "patient samples" implies these were real human urine samples, likely collected in a clinical setting. It is a retrospective or prospective study with patient samples, but the specific design isn't detailed beyond that.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document mentions "Calibration traceability: Phencyclidine with confirmation by GC/MS".
- Number of Experts: This information is not provided. GC/MS is an analytical method, not directly managed by "experts" in the sense of clinicians making diagnoses. While skilled laboratory personnel operate and interpret GC/MS results, the document doesn't quantify them or their specific qualifications.
- Qualifications of Experts: Not specified beyond the implication of trained laboratory personnel for GC/MS.
4. Adjudication Method for the Test Set:
- The document implies that Gas Chromatography/Mass Spectrometry (GC/MS) serves as the primary "ground truth" or confirmatory method. This is a highly accurate analytical technique. There is no mention of a traditional expert adjudication method (e.g., 2+1, 3+1) in the context of clinical expert agreement. The results of the VITROS PCP assay were compared to results obtained from the predicate device, which itself would have been validated against GC/MS.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC study was done. This device is an automated in vitro diagnostic (IVD) assay. Its performance is compared to another automated IVD assay and a reference method like GC/MS, not to human readers' interpretations. Therefore, there's no concept of human readers improving with AI assistance in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, a standalone study was done. The entire comparison described is a standalone performance assessment of the VITROS PCP assay (an "algorithm" in the sense of an automated test) against a predicate device and ground truth (GC/MS) without human-in-the-loop interpretation as a primary measure. The instrument ("VITROS 5,1 FS Chemistry Systems") automates the process.
7. Type of Ground Truth Used:
- The primary ground truth used is phencyclidine concentration confirmed by Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "Phencyclidine with confirmation by GC/MS" under "Calibration traceability." GC/MS is considered the "preferred confirmatory method" for drug-of-abuse test results.
8. Sample Size for the Training Set:
- The document does not provide information on a separate "training set" or its size. As this is an in vitro diagnostic device, the "training" for the assay itself would involve optimization during development, rather than a distinct machine learning-style training set of clinical data after the assay's chemical formulation is finalized. Calibrators are defined, but these aren't typically referred to as a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
- As a distinct "training set" is not mentioned in the provided text, the method for establishing its ground truth is not applicable/not provided. The calibrators (VITROS Chemistry Products Calibrator Kit 26 and VITROS Chemistry Products FS Calibrator 1) are prepared from human urine with drugs of abuse added, and their values are established through reference methods (implied to be traceable to GC/MS for phencyclidine). These calibrators are used to establish the measurement curve for the assay.
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