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510(k) Data Aggregation
(267 days)
ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03
The Abbott RealTime CT/NG (List No. 8L07-91) assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorrhoeae. The assay may be used to test the following specimens from symptomatic individuals: female endocervical swab, clinician-collected vaginal swab, and patient-collected vaginal swab specimens; male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected vaginal swab and patient-collected vaginal swab specimens; female and male urine specimens.
Abbott RealTime CT/NG consists of two reagent kits:
- · Abbott RealTime CT/NG Amplification Reagent Kit (List No. 8L07-91)
- · Abbott RealTime CT/NG Control Kit (List No. 8L07-80)
The Abbott RealTime CT/NG assay uses PCR technology with homogenous real-time fluorescence detection on the m2000 System. The Abbott m2000 System consists of the Abbott m2000sp and Abbott m2000rt instruments. The Abbott m2000 System integrates sample preparation with nucleic acid amplification and detection to generate assay results. The Abbott m2000sp is used for processing samples and the Abbott m2000rt is used for amplification and detection.
Abbott RealTime CT/NG Assay: Acceptance Criteria and Supporting Study
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Abbott RealTime CT/NG assay are implied by the reported clinical sensitivity and specificity for various specimen types and Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) detection. While explicit numerical acceptance criteria are not stated in the provided text, the reported performance values demonstrate the device's efficacy.
Table 1: Clinical Performance of Abbott RealTime CT/NG Assay
| Specimen Type & Symptom Status | Analyte | Reported Sensitivity (95% C.I.) | Reported Specificity (95% C.I.) |
|---|---|---|---|
| Female Endocervical Swab | CT | 93.8 (84.8, 98.3) | 99.8 (99.0, 100.0) |
| NG | 95.8 (88.7, 99.1) | 99.8 (99.1, 100.0) | |
| Female Clinician-Collected Vaginal Swab | CT (Symptomatic) | 98.4 (91.6, 100.0) | 100.0 (99.3, 100.0) |
| CT (Asymptomatic) | 97.2 (85.5, 99.9) | 99.3 (98.2, 99.8) | |
| NG (Symptomatic) | 98.4 (91.5, 100.0) | 99.8 (99.1, 100.0) | |
| NG (Asymptomatic) | 100.0 (71.5, 100.0) | 99.7 (98.9, 100.0) | |
| Female Self-Collected Vaginal Swab | CT (Symptomatic) | 98.4 (91.5, 100.0) | 98.9 (97.5, 99.6) |
| CT (Asymptomatic) | 97.3 (85.8, 99.9) | 99.1 (97.9, 99.7) | |
| NG (Symptomatic) | 100.0 (91.6, 100.0) | 99.8 (99.1, 100.0) | |
| NG (Asymptomatic) | 100.0 (71.5, 100.0) | 99.9 (99.3, 100.0) | |
| Female Urine | CT (Symptomatic) | 91.3 (82.8, 96.4) | 99.7 (98.9, 100.0) |
| CT (Asymptomatic) | 93.5 (82.1, 98.6) | 99.7 (98.9, 100.0) | |
| NG (Symptomatic) | 97.3 (89.3, 99.6) | 99.8 (99.1, 100.0) | |
| NG (Asymptomatic) | 95.7 (79.0, 99.9) | 99.7 (98.9, 100.0) | |
| Male Urethral Swab | CT (Symptomatic) | 93.4 (87.9, 97.0) | 98.3 (96.8, 99.2) |
| NG (Symptomatic) | 99.0 (95.9, 99.9) | 99.6 (98.9, 99.9) | |
| Male Urine | CT (Symptomatic) | 95.5 (91.4, 98.1) | 99.1 (98.0, 99.7) |
| CT (Asymptomatic) | 96.6 (90.3, 99.3) | 99.3 (98.2, 99.8) | |
| NG (Symptomatic) | 99.2 (96.3, 99.7) | 99.5 (98.7, 99.8) | |
| NG (Asymptomatic) | 100.0 (99.4, 100.0) | 100.0 (71.5, 100.0) |
2. Sample Size and Data Provenance (Clinical Study)
- Sample Size for Test Set: A total of 3,832 male and female subjects were enrolled in the multi-center clinical study. For the analysis of the Abbott RealTime CT/NG assay, 6,555 CT results and 6,569 NG results were used.
- Data Provenance: The study was conducted in the United States across 16 geographically diverse sites, including physician private practices, public and private STD clinics, and a hospital emergency room. The study design implies a prospective collection of specimens from enrolled subjects, although it's not explicitly stated as retrospective or prospective in every detail of the summary. The phrase "Specimens were collected from subjects at...sites" supports a prospective approach for the clinical data.
3. Number of Experts and Qualifications (Ground Truth)
The document does not explicitly state the "number of experts" or their specific "qualifications" used to establish the ground truth in the clinical study. Instead, the ground truth was established by comparing the Abbott RealTime CT/NG assay to reference assays.
4. Adjudication Method (Test Set)
The adjudication method for determining the "patient infected status" (ground truth) was based on a combination of reference assay results:
- For CT or NG (Female Subjects): A female was categorized as infected if a minimum of two positive results were reported (at least one from each reference NAAT). A specific condition was also applied for CT: if reference urine specimens were positive and all three reference swab specimens were negative, the subject was considered infected for urine but not swab specimens.
- For CT or NG (Male Subjects): A male was categorized as infected if a minimum of two positive results were reported.
- For NG (All Subjects): If the reference NG culture assay result was positive, the subject was categorized as infected regardless of NAAT results.
- Non-Infected Status: For females, non-infected status was assigned if at least one reference NAAT reported negative results for all sample types AND the NG culture was negative. For males, at least two negative results from reference NAATs AND a negative NG culture result were required for non-infected status.
- Subjects with missing and/or indeterminate results from reference assays were excluded from the analysis (4 subjects for CT and 7 subjects for NG).
This multi-assay, rule-based approach serves as the adjudication method for establishing the ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned in the provided document. The study is focused on the standalone performance of the Abbott RealTime CT/NG assay against established reference methods, not on comparing human reader performance with and without AI assistance.
6. Standalone Performance (Algorithm Only)
Yes, a standalone performance study was done. The entire clinical study described, measuring the sensitivity and specificity of the Abbott RealTime CT/NG assay against reference methods, represents the standalone performance of the algorithm. The results are summarized in Table 1 above, as well as Tables 3.10-3.13 in the original document.
7. Type of Ground Truth Used
The ground truth used for the clinical study was established by expert consensus using a combination of reference assays:
- Two commercially available Nucleic Acid Amplification Tests (NAATs) for CT and NG.
- Culture for NG.
This is a composite reference standard or adjudicated clinical truth based on multiple established diagnostic methods.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" or "training data" in the context of the Abbott RealTime CT/NG assay development or validation. This is expected given that the device is an in-vitro diagnostic (IVD) PCR assay, which typically relies on analytical validation and clinical performance studies described here, rather than machine learning models that require distinct training and test sets. The presented clinical study serves as the primary validation of the device's performance.
9. How the Ground Truth for the Training Set Was Established
As noted above, the document does not refer to a distinct "training set." The Limit of Detection (LOD) and analytical sensitivity studies (Sections 3.14.1), which involve testing known concentrations of CT and NG target DNA and isolates, can be considered part of the analytical validation that informs the assay's performance characteristics. For these analytical studies:
- Known concentrations of CT and NG target DNA were used.
- Dilutions of various CT serovars and NG isolates were tested.
This is a form of defined analytical ground truth based on controlled laboratory preparations of the target organisms. For the clinical performance, the ground truth was established by the composite reference standard from the clinical study as detailed in point 7.
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