(273 days)
Atlas One Step hCG Urine Pregnancy Test (Strip) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the early detection of pregnancy. The device is designed for over-the-counter use only. Additional clinical examination should be performed to confirm the pregnancy. The device is single use.
Atlas One Step hCG Urine Pregnancy Test (Cassette) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the early detection of pregnancy. The device is designed for over-the-counter use only. Additional clinical examination should be performed to confirm the pregnancy. The device is single use.
Atlas One Step hCG Urine Pregnancy Test (Midstream) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the early detection of pregnancy. The device is designed for over-the-counter use only. Additional clinical examination should be performed to confirm the pregnancy. The device is single use.
Atlas Link Technology Co., Ltd.'s One Step hCG Urine Pregnancy Test will be sold in three formats: Strip, Cassette, and Midstream. Each format of the device contains mouse monoclonal anti-beta-hCG antibody colloidal gold conjugate pre-dried on a pad. Mouse monoclonal antialpha-hCG antibodies (on test region) and goat anti-mouse IgG (on control region) are coated and immobilized on a membrane.
The Atlas One Step hCG Urine Pregnancy Test (Strip, Cassette, and Midstream) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. The device is intended for over-the-counter use.
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 provided document details various analytical performance characteristics. The primary acceptance criteria for a qualitative pregnancy test are generally high sensitivity at the claimed cut-off and high specificity (low false positives).
| Acceptance Criteria / Performance Metric | Reported Device Performance (Atlas One Step hCG Urine Pregnancy Test - Strip, Cassette, Midstream) |
|---|---|
| Sensitivity / Detection Limit | Needs to be clearly stated. The device sensitivity is 25 mIU/mL. |
| Percentage Positive at 25 mIU/mL hCG | Strip: 100% (120/120) |
| Cassette: 100% (120/120) | |
| Midstream: 100% (120/120) | |
| Percentage Negative at 0 mIU/mL hCG | Strip: 100% (120/120) |
| Cassette: 100% (120/120) | |
| Midstream: 100% (120/120) | |
| Cross-reactivity: LH (500 mIU/mL) | No interference (tested in 12.5mIU/mL and 25mIU/mL hCG samples) |
| Cross-reactivity: FSH (1000 mIU/mL) | No interference (tested in 12.5mIU/mL and 25mIU/mL hCG samples) |
| Cross-reactivity: TSH (1000 mIU/mL) | No interference (tested in 12.5mIU/mL and 25mIU/mL hCG samples) |
| Interference (various substances) | No interferences observed at specified concentrations |
| hCG ß-core fragment interference | No interference up to 1,000,000 pmol/mL (tested in 12.5mIU/mL and 30mIU/mL hCG samples) |
| Effect of urine pH | No interference within pH 3.0-10.0 |
| Specific Gravity | No interference within specific gravity 1.003-1.050 |
| High Dose Hook Effect | No hook effect up to 500,000 mIU/mL |
| Closed Pouch Real Time Stability | 36 months when stored at 2-30°C |
| Open Box Stability | Stable for up to 4 hours once opened (labeling recommends immediate testing) |
| Lay-user Interpretation Agreement | High agreement with professional interpretation (100% for positive and negative cases observed in the tables) |
2. Sample Size Used for the Test Set and Data Provenance
Analytical Performance (Precision/Reproducibility, Linearity, Analytical Specificity/Interference, Detection Limit):
- Sample Size:
- Precision/Reproducibility: 40 urine samples for each concentration (0, 12.5, 16, 20, 25, 30, 40 mIU/mL hCG). These were tested with 3 batches of each of the three device formats (Strip, Cassette, Midstream). This means 40 samples * 7 concentrations * 3 batches * 3 formats = 2,520 individual tests, with 120 tests per concentration across all batches for each format.
- Cross-reactivity: Urine samples with 12.5 mIU/mL and 25 mIU/mL hCG, spiked with various concentrations of LH, FSH, TSH. Tested with 3 batches of each format. Specific number of samples per hormone concentration not explicitly stated but implies multiple tests.
- Interference (exogenous compounds): Normal non-pregnant urine (0 mIU/mL hCG) and 25 mIU/mL hCG samples spiked with 21 different interfering substances. Tested with 3 lots of each format. Specific number of tests per substance not detailed but implied multiple tests.
- hCG beta-core fragment: Urine samples with 12.5 mIU/mL and 30 mIU/mL hCG, spiked with 5 different concentrations of hCG ß-core fragment. Tested with 3 batches of each format.
- Urine pH: Urine samples with 0 mIU/mL and 25 mIU/mL hCG at 11 different pH values (3.0-10.0). Tested with 3 batches of each device.
- Specific Gravity: 0 mIU/mL and 25 mIU/mL hCG samples adjusted to specific gravities from 1.003-1.050. Tested with 3 lots of each format.
- Hook Effect: hCG-free urine spiked with 6 different high hCG concentrations (1,000 to 5,000,000 mIU/mL). Tested on three lots of devices for each format.
- Data Provenance: The document does not explicitly state the country of origin for the urine samples used in analytical studies. The device manufacturer is in China, so it's likely the studies were conducted there. These appear to be retrospective studies using spiked samples to evaluate analytical performance.
Method Comparison with Predicate Devices:
- Sample Size: 300 urine samples collected from women aged 18 to 45 (100 samples per device format: Strip, Cassette, Midstream). These samples were from non-pregnant, pregnant, or women with later periods/ready to be pregnant.
- Data Provenance: Samples collected from two different hospitals. The country of origin for these hospitals is not specified but is likely China, where the manufacturer is located. This study is prospective as samples were collected and then tested.
Lay-user Studies:
- Sample Size: 300 lay users, each testing their own urine with one test method (100 for Strip, 100 for Cassette, 100 for Midstream). Ages ranged from 18 to 45 years.
- Data Provenance: Not explicitly stated, but likely in China in connection with the hospitals mentioned in the professional method comparison. This is a prospective study involving direct user testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
For Analytical Performance (Spiked Samples):
The ground truth was established by virtue of precisely spiking known concentrations of hCG and other substances into urine samples. No external experts were used to establish this ground truth; it was determined by the laboratory's preparation of the samples.
For Method Comparison with Predicate Devices:
The ground truth for the method comparison appears to be the predicate device's results, interpreted by a professional. The document states that "Results of the professional using the candidate device were compared to results obtained from the predicate device."
- Number of Experts: Not explicitly stated. It refers to "the professional," which could imply a single professional or multiple, but the number is not quantified.
- Qualifications of Experts: Not specified beyond "professional" or "laboratory professional."
For Lay-user Studies:
The ground truth was established by having a laboratory professional at the hospital interpret the same sample that the lay user tested.
- Number of Experts: Not explicitly stated. Refers to "a laboratory professional."
- Qualifications of Experts: Not specified beyond "laboratory professional."
4. Adjudication Method for the Test Set
For Analytical Performance (Spiked Samples):
No adjudication method was needed for the "ground truth" as it was based on known spiked concentrations. For the device's readings, "more than three operators" conducted the precision study. It is not stated how discrepancies among operators were resolved, but the results are presented as percentages positive/negative.
For Method Comparison with Predicate Devices:
The study design directly compares the candidate device's interpretation by a professional to the predicate device's results. It's a direct comparison against a "reference standard" (the predicate). No explicit adjudication method (like 2+1) is described for resolving conflicts between the candidate device results itself or between the candidate and predicate results. However, the tables implicitly assume concurrence between the professional's interpretation of the predicate device and the true clinical status.
For Lay-user Studies:
The lay user's interpretation was compared to the interpretation of the "candidate device professional." This implies the professional's reading served as the reference standard for evaluating the lay user's ability to interpret the device. No specific adjudication method is mentioned beyond this comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a traditional MRMC comparative effectiveness study, as typically understood in oncology or radiology (comparing human readers with AI assistance versus without AI assistance), was not explicitly performed.
The studies focused on:
- Analytical performance of the device itself.
- Method comparison of the candidate device (read by a professional) against a predicate device.
- Lay-user study comparing lay user interpretation against a professional's interpretation of the same candidate device.
There is no AI component in this device as it is a "visually-read, lateral flow immunoassay." Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. Standalone Performance Study
Yes, a standalone performance study was clearly performed. The analytical performance section (Precision/Reproducibility, Linearity, Analytical Specificity/Interference, Detection Limit, Hook Effect, Stability, etc.) describes the performance of the algorithm (in this case, the immunoassay device) only, without human interpretation being the primary variable. The results from these studies demonstrate the device's inherent capability to detect hCG at various concentrations and under different conditions.
7. Type of Ground Truth Used
- Analytical Performance: The ground truth was established through known concentrations of hCG (traceable to WHO 5th International Standard) in spiked urine samples. For interference studies, known concentrations of interfering substances were added.
- Method Comparison with Predicate Devices: The ground truth was the results obtained from the predicate device (K071930), as interpreted by a professional. This can be considered a "reference standard" within the context of substantial equivalence.
- Lay-user Studies: The ground truth for evaluating lay user performance was the interpretation of the candidate device by a "laboratory professional" using the same urine sample.
8. Sample Size for the Training Set
This submission describes a medical device (a pregnancy test kit) and its analytical and clinical performance studies, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development. The device relies on a chemical immunoassay, not a learned algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm, this question is not applicable.
§ 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.