(174 days)
The Access Total BhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total βhCG levels in human serum and plasma using the Access Immunoassay Systems. This assay is intended for use as an aid in the early detection of pregnancy.
The Access Total βhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total βhCG levels in human serum and plasma using the Access Immunoassay Systems. This assay is intended for use as an aid in the early detection of pregnancy.
Here's a breakdown of the acceptance criteria and study information for the Access Total βhCG (5th IS) device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Method Comparison | R² ≥ 0.90 and slope 1.00 ± 0.10 | Met acceptance criteria (R² and slope not explicitly stated, but deemed met) |
| Bias Estimate | Reference intervals on Access 2 system not appreciably changed on Dxl 9000 system | Supports reference intervals have not changed appreciably |
| Imprecision | N/A (criteria not explicitly stated for all ranges) | Within-laboratory (total) % CV ranged from 2.5% to 4.7% for hCG concentrations > 3.9 mIU/mL |
| Within-laboratory (total) SD ranged from 0.04 to 0.06 for hCG concentrations ≤ 3.9 mIU/mL | ||
| Linearity | Non-linearity within ± 0.39 mIU/mL for values ≤ 3.9 mIU/mL | Met acceptance criteria (non-linearity within specified ranges) |
| Non-linearity within ± 10.0% for values > 3.9 mIU/mL | Met acceptance criteria | |
| Reproducibility | SD ≤ 0.51 for values ≤ 3.9 mIU/mL | Met design input requirements (SD ≤ 0.51 for values ≤ 3.9 mIU/mL) |
| CV 3.9 mIU/mL | Met design input requirements (CV 3.9 mIU/mL) | |
| Limit of Blank (LoB) | N/A (result provided as estimate) | LoB estimate of 0.1 mIU/mL |
| Limit of Detection (LoD) | N/A (result provided as estimate) | LoD estimate of 0.2 mIU/mL |
| Limit of Quantitation (LoQ) | 20% CV AND recovery of ± 0.1 mIU/mL for three reagent lots (when compared to WHO 5th International Standard) | LoQ determined to be 0.6 mIU/mL (IU/L) |
2. Sample Size and Data Provenance for Test Set
The document does not explicitly state the specific sample sizes used for each test (e.g., Method Comparison, Imprecision, Linearity, Reproducibility, LoB/LoD/LoQ). It discusses general results of "studies" but doesn't provide granular details on the number of samples or specimens.
The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is an in vitro diagnostic (IVD) immunoassay for the quantitative determination of total βhCG levels. The ground truth for such devices is typically established through analytical methods and reference standards, not through expert human interpretation of images or clinical cases.
4. Adjudication Method for Test Set
Not applicable. As this is an IVD immunoassay, an "adjudication method" involving human experts (like 2+1 or 3+1 for clinical case interpretation) is not relevant. The performance is assessed against analytical criteria and reference standards.
5. MRMC Comparative Effectiveness Study
Not applicable. This is an in vitro diagnostic (IVD) device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.
6. Standalone (Algorithm Only) Performance
Yes, the studies described (Method Comparison, Imprecision, Linearity, Reproducibility, LoB/LoD/LoQ) demonstrate the standalone performance of the Access Total βhCG (5th IS) assay on the DxI 9000 Access Immunoassay Analyzer. These are analytical performance characteristics of the device itself, without human-in-the-loop interpretation.
7. Type of Ground Truth Used
The ground truth for the analytical performance studies (such as LoQ determination) was established by comparison to the WHO 5th International Standard for Chorionic Gonadotropin (NIBSC Code 07/364). This is a recognized international reference standard.
8. Sample Size for Training Set
Not applicable. This is an immunoassay, which does not typically involve a "training set" in the context of machine learning algorithms. Its design and calibration are based on chemical principles and validation against reference materials.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the machine learning sense for this device. The ground truth for ensuring the device's accuracy and performance is established through rigorous analytical verification using reference standards like the WHO International Standard.
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.