(198 days)
This product is intended for use as an unassayed control material on the Abbott LCx Probe System with the Abbott Chlamydia Amplification Kit in the qualitative determination of Chlamydia trachomatis.
This product is intended to serve as an unassayed control material to monitor the analytical precision of the LCR amplification system incorporated in the Abbott LCx Probe System used in conjunction with the Abbott Chlamydia Amplification Kit. Response ratios (S/CO) have been set at appropriate positive (+) and negative (-) levels.
This product is intended for in vitro use only.
The DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS Control is composed of plastic screw cap bottles, 2 mL each, containing two (2) levels of control, positive and negative, for Chlamydia trachomatis in a stabilized biological matrix. The formulation design provides a liquid matrix that is compatible with the Abbott Chlamydia Amplification Kit for assay on the LCx Probe System for the direct, qualitative determination of Chlamydia trachomatis.
The provided text describes a 510(k) submission for a Chlamydia trachomatis control device and does not contain information about the acceptance criteria or a study demonstrating the device meets those criteria in the way a typical AI/medical device performance study would. It primarily focuses on the device's characteristics, intended use, and comparison to predicate devices for regulatory clearance.
However, I can extract the relevant information that would be considered "acceptance criteria" and "device performance" in the context of this regulatory submission, even if it's not a quantitative clinical study. For a control device, the "acceptance criteria" revolve around its functionality in a diagnostic system, and "performance" is demonstrated by its successful use with the specified assay.
Here's an interpretation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For a control device, the "acceptance criteria" are implied by its intended use and the "performance" is its functionality within the specified diagnostic system.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| For Negative Control: | |
| Is recognized as negative by the Abbott LCx Probe System with the Abbott Chlamydia Amplification Kit. | "Response ratios (S/CO) have been set at appropriate ... negative (-) levels." |
| Monitors analytical precision of the LCR amplification system. | Intended to "monitor the analytical precision of the LCR amplification system." |
| Performs as an unassayed negative control. | "Unassayed control intended for use with the Abbott Chlamydia Amplification Kit in the Abbott LCx Probe System for the direct, qualitative determination of Chlamydia trachomatis." |
| For Positive Control: | |
| Is recognized as positive by the Abbott LCx Probe System with the Abbott Chlamydia Amplification Kit. | "Response ratios (S/CO) have been set at appropriate positive (+) ... levels." |
| Monitors analytical precision of the LCR amplification system. | Intended to "monitor the analytical precision of the LCR amplification system." |
| Performs as an unassayed positive control. | "Unassayed control intended for use with the Abbott Chlamydia Amplification Kit in the Abbott LCx Probe System for the direct, qualitative determination of Chlamydia trachomatis." |
| General Characteristics: | |
| Volume: 2 mL | 2 mL |
| Matrix: Stabilized biological matrix | Stabilized biological matrix |
| Dilution: None required | None required |
| Unopened Stability: 12 Months | Until Expiration Date 12 Months |
| Open Stability: 30 Days | 30 Days |
| Compatible with Abbott Chlamydia Amplification Kit on LCx Probe System. | Designed for use with "Abbott Chlamydia Amplification Kit for assay on the LCx Probe System." |
2. Sample size used for the test set and the data provenance
The document does not detail a specific "test set" in the context of a performance study with a defined sample size as would be expected for a diagnostic or AI device. Instead, the "testing" described is implicitly the characterization and verification of the control material's properties (stability, compatibility, intended response levels) in conjunction with the Abbott LCx system, likely performed during product development and validation by the manufacturer (CASCO Standards).
- Sample Size: Not explicitly stated as a number of "cases" or "patients." It refers to levels of control material (positive and negative).
- Data Provenance: The context suggests this is internal validation data generated by CASCO Standards in the US, used for regulatory submission. It is retrospective in the sense that the data was collected prior to the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not directly applicable to a control device like this one. For a control, the "ground truth" is inherent to the control's design and formulation (i.e., it is a positive control, it is a negative control). The performance is linked to whether the control behaves as expected within the validated diagnostic system. There are no "experts" establishing a disease state ground truth for individual samples.
4. Adjudication method for the test set
Not applicable. There's no "adjudication" in the sense of resolving discrepancies between human readers or reconciling different assessments of clinical cases. The performance is determined by the output of the LCx Probe System in response to the control material.
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 a diagnostic control, not an AI-powered diagnostic tool, and it does not involve human readers interpreting results in a clinical context that would necessitate an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a standalone performance study for an algorithm. Not applicable, as this is a physical control material, not an algorithm. The "standalone" performance here refers to the control itself functioning correctly with the specified instrument system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this control device, the "ground truth" is defined by the composition and intended behavior of the control material itself. The negative control is formulated to be negative for Chlamydia trachomatis, and the positive control is formulated to elicit a positive response for Chlamydia trachomatis in the specified diagnostic system. This is an engineered ground truth, established during the design and manufacturing of the control. The predicate devices (Abbott LCx Chlamydia Negative Control and Human Urine Positive for Chlamydia trachomatis) serve as benchmarks for the expected performance.
8. The sample size for the training set
Not applicable. This device is a control material, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.