(255 days)
The HCG Home Use Pregnancy Test Strip (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
The test strip is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only.
The HCG Home Use Pregnancy Test Cassette (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test cassette is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only.
The HCG Home Use Pregnancy Test Midstream (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test midstream is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only.
The HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold) and HCG Home Use Pregnancy Test Midstream (Colloidal Gold) utilize a combination of antibodies including a monoclonal HCG antibody to selectively detect elevated levels of HCG. The detection method is to observe the formation of colored lines when testing urine samples with test devices. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-HCG-colored conjugate and form a red colored line at the test line region of the membrane. The absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear in the control line region if the test has been performed properly. HCG Pregnancy Test will be sold in three different formats: Cassette, Strip, and Midstream. The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and an Instruction. The Cassette format contains a test device, a dropper, a collection container and an Instruction. The test uses two red lines to indicate results. Two distinct red lines appear in the control region (C) and test region (T) means the test is "positive". Only one red line appears in the control region(C). No apparent line in the test region (T). means the test is "negative". If No coloured line appears in the control region (C), or if there is no color band in control region (C) even there is a band in the test region (T),this means "invalid" test result.
The provided text describes different aspects of the HCG Home Use Pregnancy Test devices, including acceptance criteria and study results. However, it does not explicitly state acceptance criteria in a dedicated section with pass/fail metrics. Instead, the performance characteristics implicitly define the acceptance criteria by demonstrating performance comparable to the predicate device and meeting expected analytical standards for a qualitative pregnancy test. I will synthesize the information to best answer your request.
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit numerical acceptance criteria are not stated, I will infer them from the reported analytical performance deemed acceptable for demonstrating substantial equivalence. The predicate device's characteristics also serve as an implicit benchmark.
| Acceptance Criteria (Inferred from Analytical Performance and Predicate) | Reported Device Performance (HCG Home Use Pregnancy Test) |
|---|---|
| Analytical Sensitivity: 25mIU/mL HCG detection threshold | Analytical Sensitivity: 25mIU/mL HCG |
| Specificity (Cross-reactivity): No interference from HCG-related hormones | Specificity (Cross-reactivity): No interference at hLH (500mIU/mL), hFSH (1000mIU/mL), hTSH (1mIU/mL) |
| pH Interference: No interference within physiological urine pH range | pH Interference: No interference for urine with pH 3-9 |
| Specific Gravity Interference: No interference within physiological urine specific gravity range | Specific Gravity Interference: No interference for urine with Specific Gravity 1.000-1.035 |
| High-Dose Hook Effect: No false negatives at high HCG concentrations | High-Dose Hook Effect: No hook effect observed up to 1,000,000 mIU/mL |
| HCG ß-core fragment interference: No interference | HCG ß-core fragment interference: No interference up to 1,000,000 pmol/L |
| Precision/Reproducibility: Consistent results across lots, days, and sites for specified HCG concentrations | Precision/Reproducibility: Excellent consistency reported across 3 lots, 5 days/2 runs per day, 3 operators, and 3 sites, with 100% detection at 25 mIU/mL and above. |
| Method Comparison with Predicate Device: 100% agreement between candidate and predicate devices for positive and negative samples. | Method Comparison with Predicate Device: 100% agreement (50 positive, 50 negative) across Strip, Cassette, and Midstream formats when compared to predicate. |
| Lay User Study: High agreement between lay user results and professional results using the predicate device. | Lay User Study: 100% agreement (50 positive, 50 negative) across Strip, Cassette, and Midstream formats when self-tested by lay users compared to professional predicate results. |
2. Sample Size Used for the Test Set and Data Provenance
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Analytical Performance Studies (Precision, Specificity, Interference, etc.):
- Precision/Reproducibility (Intra-batch, Inter-batch): For each of the three device formats (Strip, Cassette, Midstream), 3 lots were tested. For each lot and each of the 6 HCG concentration levels (0, 12.5, 18.75, 25, 50, 100 mIU/mL), 20 samples were tested. Total samples: 3 formats * 3 lots * 6 concentrations * 20 samples = 1080 samples.
- Precision/Reproducibility (Inter-day, Inter-round): For each of the three device formats, 3 lots were tested. Over 5 days, with 2 runs per day, three operators tested blinded and randomized samples. For each lot and each of the 6 HCG concentration levels, the number of tests was (5 days * 2 runs per day * 20 samples) = 200 samples. Total samples: 3 formats * 3 lots * 6 concentrations * 200 samples = 10,800 samples.
- Inter-laboratory Precision: For each of the three device formats, tests were performed at 3 sites using 3 lots. For each site, lot, and each of the 6 HCG concentration levels, the number of tests was (3 sites * 3 lots * 20 samples (implied from the table similar to batch precision)). Total samples: 3 formats * 3 sites * 3 lots * 6 concentrations * 20 samples = 3240 samples.
- Cross-reactivity: Tested with specific concentrations of hLH, hFSH, hTSH using 3 lots of the test kits. The exact number of individual samples tested for each reactant is not specified, but it's stated "no cross reactivity was observed."
- Interference: Tested with various common substances at specific concentrations for urine samples containing 0, 10, and 25 mIU/mL hCG. Three batches of each format were tested. The exact number of individual samples tested for each substance is not specified.
- High Dose Hook Effect: 10 hCG-free specimens spiked at various high concentrations (5,000 to 1,000,000 mIU/mL) were tested on three lots of devices for each format. Total samples: 10 specimens * 8 concentrations * 3 lots * 3 formats = 720 samples.
- HCG β-core fragment: Normal non-pregnant women urine specimens (0, 10, 25 mIU/mL hCG) spiked with varying concentrations of β-core fragment. Three lots of each format were tested. The exact number of individual samples tested is not specified.
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Clinical Studies (Method Comparison and Lay User Study):
- Method Comparison with Predicate Device: A total of 300 urine samples from females of childbearing age (18 to 48 years) were collected. These were split for the 3 device formats: 100 for Strip, 100 for Cassette, 100 for Midstream. Within each device format, 50 positive and 50 negative samples were used.
- Lay User Study: 300 women participated (100 for each device format: Strip, Cassette, Midstream). Each woman tested her own urine sample. Within each device format, 50 positive and 50 negative samples were used.
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Data Provenance:
- Origin: The submitter is Anhui DEEPBLUE Medical Technology Co. LTD., located in Hefei, Anhui, People's Republic of China, and the designated correspondent is in Shanghai, China. The document does not explicitly state the country of origin for the samples, but given the company's location, it is highly likely the studies were conducted in China.
- Retrospective or Prospective: The studies (both analytical and clinical) appear to be prospective as samples were collected and tested as part of the study design ("samples were collected at various time throughout the day and were randomized prior to testing," "A total of 300 urine samples from females of childbearing age were collected in this clinical trial").
3. Number of Experts and Qualifications
- Analytical Studies: "different operator" and "three operators" are mentioned for precision studies. No specific expert qualifications (e.g., radiologist) are provided, but these would typically be laboratory technicians or trained personnel.
- Clinical Studies (Method Comparison): "laboratory professionals at 3 clinical study unit" performed testing with the candidate device. "Results reported by a laboratory professional using the predicate device" were used for comparison in the lay user study. No specific qualifications beyond "laboratory professionals" are given.
- Ground Truth Establishment: The ground truth for HCG concentrations in analytical studies was established by spiking pooled negative female urine with HCG traceable to WHO 5th International Standards. For clinical studies, the predicate device results, as interpreted by laboratory professionals, served as the comparative ground truth.
4. Adjudication Method
- The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in the test results. For the precision studies, multiple operators and lots were used to demonstrate consistency, but no specific adjudication process for conflicting results is mentioned. For the method comparison and lay user studies, results were compared directly, and 100% agreement was reported, implying no need for adjudication for those specific metrics.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. The studies compared the device's performance to established HCG concentrations (analytical) or to a predicate device (clinical), and also assessed lay user performance against professional predicate results. There is no mention of comparing human readers' performance with and without AI assistance, as these are qualitative, visually-read home-use pregnancy tests, not AI-assisted imaging devices.
6. Standalone (Algorithm Only) Performance
- Yes, the device's analytical performance (sensitivity, specificity, interference, hook effect) can be considered its "standalone" performance, as it quantifies the ability of the test strip/cassette/midstream itself to detect/react to HCG in urine according to its chemical and biological design. The "method comparison" and "lay user study" sections further demonstrate the device's performance when interpreted by either professionals or lay users. Since this is a qualitative immunoassay, the "algorithm" is the biochemical reaction itself and the visual interpretation of colored lines.
7. Type of Ground Truth Used
- Analytical Studies:
- For sensitivity and precision, the ground truth was known HCG concentrations in urine achieved by spiking pooled negative female urine with HCG (traceable to WHO 5th International Standard).
- For specificity and interference, the ground truth involved known concentrations of potential interfering substances or cross-reactants.
- Clinical Studies (Method Comparison and Lay User Study):
- The ground truth was established by the results of the predicate device as interpreted by laboratory professionals. This implies that the predicate device is considered the gold standard for comparison in these studies.
8. Sample Size for the Training Set
- This document describes performance studies for a medical device (HCG Home Use Pregnancy Test Strip, Cassette, Midstream). These devices are rapid chromatographic immunoassays and do not involve machine learning or AI models, therefore, there is no concept of a "training set" in the context of the provided information. The studies described are for validation of the device's analytical and clinical performance.
9. How the Ground Truth for the Training Set Was Established
- As stated above, this device does not utilize a training set in the machine learning sense.
§ 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.