(262 days)
The ACCU NEWS One Step Pregnancy Test Strip: The ACCU NEWS One Step Pregnancy Test Strip is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.
ACCU NEWS One Step Pregnancy Test Cassette: The ACCU NEWS One Step Pregnancy Test Cassette is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.
ACCU NEWS One Step Pregnancy The ACCU NEWS One Step Pregnancy Test Midstream is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic Gonadotropin (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.
ACCU NEWS "M One Step hCG Pregnancy Test is a qualitative lateral flow test for the detection of hCG (human chorionic gonadotropin) hormone, which is present in urine during the early stage of pregnancy. It is built on a basic lateral flow immunoassay test strip model containing 6 components as illustrated below:
The nitrocellulose membrane is coated with Goat anti-mouse IgG polyclonal antibody on the control line and anti-alpha hCG mouse monoclonal antibody on the test line. The conjugate pad contains colloidal-gold-labeled anti-beta mouse monoclonal hCG antibody. When urine specimen is drawn through the sample pad, the hCG present in the urine will react with the anti-beta monoclonal hCG antibody on the conjugate pad and the antialpha monoclonal hCG antibody on the test line to develop visible lines in the test region.
The ACCU NEWS TM One Step hCG Pregnancy Test is available in three different formats: 1) strip, 2) cassette, and 3) midstream.
The provided text describes the acceptance criteria and a study demonstrating the performance of the ACCU NEWS™ One Step hCG Pregnancy Test.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Performance Metric | Predicate Device Performance (K043443 Wondfo One Step HCG Urine Pregnancy Test) | ACCU NEWS™ One Step hCG Pregnancy Test Performance |
|---|---|---|
| Detection Limit | 25 mIU/mL | 25 mIU/mL |
| Read Time Window | 3-5 minutes | 5 minutes (optimal) |
| High Dosage Hook Effect | No high dosage hook effect up to 100,000 mIU/mL | No high dosage hook effect up to 500,000 mIU/mL |
| Specificity (LH) | LH at 300 mIU/mL | LH at 1000 mIU/mL |
| Specificity (FSH) | FSH at 300 mIU/mL | FSH at 1000 mIU/mL |
| Specificity (TSH) | TSH at 1000 μIU/mL | TSH at 1000 μIU/mL |
| pH Interference | No interference for urine with pH 4-9 | No interference for urine with pH 2-9 |
| Specific Gravity Interference | No interference for urine with Specific Gravity 1.000-1.050 | No interference for urine with Specific Gravity 1.003-1.030 |
| Comparison Study Agreement | Not explicitly stated as an acceptance criterion for the predicate, but implied 100% agreement between subject and predicate device tests | 100% agreement with predicate device results |
| OTC Lay-User Agreement | Not applicable (not for predicate comparison) | 100% agreement between lay user and professional results |
| Shelf-life Stability | Not explicitly stated | 2 years at 4-30°C (accelerated testing at 60°C) |
2. Sample Size Used for the Test Set and Data Provenance:
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Precision/Sensitivity Study:
- Test Set Sample Size: For each of the three formats (Strip, Cassette, Midstream), and for each of 6 hCG concentrations (0, 12.5, 18.75, 25, 50, 100 mIU/mL), at least 30 urine samples were tested. This means a minimum of 3 (formats) * 6 (concentrations) * 30 (samples) = 540 samples were used in total across the three lots for each format.
- Data Provenance: Urine samples were used. The study was carried out at three sites (one internal site and two external sites), implying a mix of internal and potentially external, real-world data points. The text doesn't specify the country of origin of the data, but the company is based in Carlsbad, CA, USA. The study appears to be prospective in nature, as specific experiments were designed and performed to evaluate the device.
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Comparison Study:
- Test Set Sample Size: 250 female donors. Urine samples were collected from these donors.
- Data Provenance: Urine samples were randomly collected from 250 female donors from three sites at various times throughout the day. The text doesn't specify the country of origin. This appears to be a prospective study.
-
OTC Lay-User Test Result:
- Test Set Sample Size: 250 female donors.
- Data Provenance: Urine samples were randomly collected from 250 female donors at three sites. This appears to be a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
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Precision/Sensitivity Study: The "ground truth" for the hCG concentrations (0, 12.5, 18.75, 25, 50, 100 mIU/mL) was established by external calibration against the hCG standard WHO 3rd IS. This implies laboratory standards rather than clinical expert consensus for ground truth on concentration. The results were then read by individuals at the testing sites, but their specific qualifications as "experts" for establishing ground truth are not detailed beyond "each site tested a unique lot of test device."
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Comparison Study & OTC Lay-User Test Result:
- For the comparison study and the OTC lay-user study, the "ground truth" for the pregnancy status of the 250 urine samples was primarily established by the predicate hCG test. Healthcare professionals also tested the urine samples with the ACCU NEWS™ devices, and their results served as a professional ground truth for the lay-user comparison. The qualifications of these "healthcare professionals" are not specified (e.g., radiologist, lab technician, nurse), nor is the exact number of such professionals.
4. Adjudication Method for the Test Set:
- No explicit adjudication method (like 2+1 or 3+1) is described for resolving discrepancies in any of the studies.
- In the Precision/Sensitivity study, the results are presented as counts for '+' and '-' readings for each lot and concentration, and there's no mention of adjudication if readings differed.
- In the Comparison Study and OTC Lay-User Test Result studies, 100% agreement was observed between the subject device and the predicate device/healthcare professional readings, so no adjudication would have been needed to reconcile conflicting results.
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:
- No MRMC comparative effectiveness study was done using AI. This device is a lateral flow immunoassay (a rapid diagnostic test), not an AI-powered diagnostic tool requiring human interpretation with or without AI assistance. The "readers" are either the device itself (for objective lines) or human users interpreting the lines.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is not an algorithm. It is a physical diagnostic test (lateral flow immunoassay). The "standalone" performance is essentially what is measured in the Precision/Sensitivity study, where the device's ability to detect various hCG concentrations is assessed directly.
7. The Type of Ground Truth Used:
- Precision/Sensitivity Study: The ground truth was known hCG concentrations in urine samples, calibrated against the WHO 3rd International Standard. This can be considered a form of a reference standard or analytical ground truth.
- Comparison Study: The ground truth was the results from a legally marketed predicate hCG test device. This is a comparative ground truth established against an existing, approved method.
- OTC Lay-User Test Result: The ground truth for lay-user performance was the results obtained by healthcare professionals using the ACCU NEWS™ device. This is a form of expert consensus/reference reading as ground truth for evaluating ease of use and interpretation by non-professionals.
8. The Sample Size for the Training Set:
- The document does not describe a "training set" in the context of machine learning or AI models. This device is a chemical immunoassay, not an AI-driven system. The development of the device would have involved internal R&D and optimization, but not formal "training sets" in the AI sense.
9. How the Ground Truth for the Training Set was Established:
- As there is no "training set" in the context of an AI/ML model for this device, this question is not applicable. The development of the device's components and design would have been based on established clinical chemistry principles and validated through iterative testing and quality control processes.
§ 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.