(64 days)
The Kangzhou One Step hCG Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use.
The Kangzhou One Step hCG Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use.
The Kangzhou One Step hCG Test Midstream is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use.
The Pregnancy One Step Rapid Test is a qualitative, solid phase, two-site sandwich immunoassay for the detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. The membrane is pre-coated with anti-hCG antibodies on the test band region and anti-mouse antibodies on the control band region. During testing, the urine sample reacts with the dye conjugate (mouse anti-hCG antibody-colloidal gold conjugate) which has been pre-coated on the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action to react with anti-hCG antibodies on the membrane and generate a red band. Presence of the red band indicates a positive result, while its absence indicates a negative result. Regardless of the presence of hCG, as the mixture continues to migrate across the membrane to the immobilized goat anti-mouse region, a red band at the control band region will always appear. The presence of this red band serves as verification for sufficient sample volume and proper flow and as a control for the reagents.
The provided FDA 510(k) summary for the Kangzhou One Step hCG Test Strip, Cassette, and Midstream indicates the acceptance criteria and performance of the device.
Here's an analysis of the provided information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Explicitly Stated or Implied by Study Design) | Reported Device Performance |
|---|---|---|
| 1. Analytical Performance | ||
| a. Precision/Reproducibility | Consistent results across multiple runs, days, laboratories, and batches for spiked samples at 0 mIU/mL, 12.5 mIU/mL, 18.75 mIU/mL, 25 mIU/mL, 50 mIU/mL, and 100 mIU/mL. | 100% agreement (30/30 for each category, for 3 lots) for negative (0, 12.5, 18.75 mIU/mL) and positive (25, 50, 100 mIU/mL) samples across 3 lots, 3 runs/day for 10 days, in 3 hospital laboratories, for all three formats (strip, cassette, midstream - both dip and simulated midstream methods). |
| b. Detection Limit/Sensitivity | Detect hCG at 25 mIU/mL. | 25 mIU/mL (derived from precision data, where 25 mIU/mL samples consistently showed positive results). |
| c. Analytical Specificity (Cross-reactivity) | No cross-reactivity with hLH at 500 mIU/mL, hFSH at 1000 mIU/mL, and hTSH at 1000 mIU/mL for both negative and positive (25 mIU/mL hCG) samples. | No cross-reaction observed with hLH at 500 mIU/mL, hFSH at 1000 mIU/mL, and hTSH at 1000 mIU/mL. 100% agreement (60/60 for each hormone and concentration) for negative and positive samples across 3 lots. |
| d. Analytical Specificity (Interfering Substances) | No interference from specified exogenous compounds and clinical conditions at given concentrations for both negative (0 mIU/mL) and positive (25 mIU/mL hCG) samples. | No interferences observed from a long list of substances (e.g., Acetaminophen, Aspirin, Ascorbic acid, Glucose, Hemoglobin, Albumin, Bilirubin, Leukocyte, Erythrocytes, Uric acid, Ketone, Ethanol) at their specified concentrations. |
| e. Analytical Specificity (hCG ß-core fragment) | No interference from hCG ß-core fragment at high levels (125,000, 50,000, 500,000 and 1,000,000 pmol/mL) for negative (0 mIU/mL) and positive (25 mIU/mL hCG) samples. | No interference observed in the test result at the highest levels of hCG ß-core fragment. |
| f. pH Interference | No interference for urine with pH 3-9. | Varying pH ranges (3 to 9 in 1 pH unit increments) do not interfere with the performance of the test for 0 mIU/mL and 25 mIU/mL hCG. |
| g. Specific Gravity Interference | No interference for urine with specific gravity 1.000-1.040. | No interference observed when specific gravity is between 1.01-1.04 (tested with purified water and 25 mIU/mL hCG). |
| h. High-Dose Hook Effect | No high-dose hook effect within a specified hCG concentration range. | No high-dose hook effect for hCG up to 1,000,000 mIU/mL. Positive results were obtained over the range of 62,500 to 1,000,000 mIU/mL, though the T-line lightened for concentrations above 125,000 mIU/mL. |
| 2. Professional Method Comparison | High agreement with predicate device when tested by laboratory professionals. | 100% agreement with the predicate device (Co-Innovation One Step hCG Test) for all formats (strip: 43 positive, 47 negative; cassette: 37 positive, 53 negative; midstream dip: 55 positive, 35 negative; midstream simulated: 50 positive, 40 negative) across two professional laboratories. |
| 3. Lay User Method Comparison | High agreement between lay users and professional laboratory results using the candidate device. | - Strip: 100% (43 Positive, 47 Negative). |
Cassette: 100% (37 Positive, 53 Negative).Midstream (dip method): 100% (55 Positive, 35 Negative).Midstream (actual midstream method): 100% (50 Positive, 40 Negative). |
| 4. Performance Tested by OTC User | Lay users, including untrained operators, should obtain correct results comparable to professional users, and find the test easy to read and interpret. | 100% agreement (30/30 for positive 31.25 mIU/mL and 30/30 for negative 18.75 mIU/mL) for all formats tested by lay users compared to masked spiked samples tested by professional users. All participants found the test "very easy" or "easy" to read and interpret. |
| 5. Clinical Cut-off | 25 mIU/mL | 25 mIU/mL |
Study Details
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Sample Size used for the test set and the data provenance:
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Precision/Reproducibility: 30 clinical samples (urine) from normal, non-pregnant females, spiked with hCG at different concentrations (0, 12.75, 25, 25, 100 mIU/mL - note the repeated 25 mIU/mL in the text, likely a typo for an additional concentration or indication of testing at the cut-off).
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Analytical Specificity (Cross-reactivity): 60 fresh urine specimens from healthy non-pregnant females.
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Analytical Specificity (Interfering Substances): Normal, non-pregnant female urine specimens (number not specified but implied to be sufficient for testing various substances in both 0 and 25 mIU/mL hCG spiked samples).
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Analytical Specificity (hCG ß-core fragment): Normal non-pregnant female urine specimens (number not specified but implied to be sufficient for testing different fragment concentrations in both 0 and 25 mIU/mL hCG spiked samples).
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pH & Specific Gravity Interference: Aliquots of a negative urine pool and specimens with 25 mIU/mL hCG.
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High-Dose Hook Effect: HCG-free specimens spiked with hCG at various high concentrations.
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Professional Method Comparison: Urine samples from 360 women (patients suspected of pregnancy, late periods, or later in pregnancy).
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Lay User Method Comparison: Urine samples from 360 women (same as professional comparison, but tested by lay users).
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Performance Tested by OTC User: 240 aliquots of spiked urine samples (120 at 18.75 mIU/mL and 120 at 31.25 mIU/mL hCG). 240 female subjects participated.
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Data Provenance:
- Precision/Reproducibility: Clinical samples from China (implied by manufacturer location). Data collected from 3 hospital laboratories.
- Professional Method Comparison: Urine samples collected from hospitals (implied by "women at hospital laboratory") in China (implied by manufacturer location).
- Lay User Method Comparison: Urine samples collected from hospitals (implied by "women at hospital laboratory") in China.
- Performance Tested by OTC User: The study was performed at 3 different point-of-care sites in Shanghai, Qingdao, and Beijing, China.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Precision/Reproducibility: The spiked samples' concentrations were determined by immunoassay of ELISA, implying a laboratory setting and likely qualified personnel, but the specific number or qualifications of "experts" for ground truth are not stated.
- Professional Method Comparison: Ground truth was established by comparing the candidate device to a legally marketed predicate device (K132085, Co-Innovation One Step hCG Test Strip/Cassette/Midstream), tested by "laboratory professionals" (number and specific qualifications not mentioned).
- Lay User Method Comparison: Ground truth for professional comparison was the predicate device. For the comparison of lay user results to candidate device professional results, the ground truth was the professional interpretation of the candidate device. "Laboratory professionals" are mentioned, but their number and specific qualifications are not.
- Performance Tested by OTC User: Ground truth was established by "professional laboratory personnel at the manufacturer site" testing "masked spiked urine." The number and specific qualifications of these personnel are not stated.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not explicitly describe an adjudication method with multiple readers for discrepancy resolution (like 2+1 or 3+1). For the professional method comparison and lay user comparison, agreement was measured against a reference method (predicate device or professional readings of the candidate device). For spiked samples, the known concentration (via ELISA) served as the objective reference.
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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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a rapid diagnostic test (HCG pregnancy test) and AI assistance is not part of its design. The studies performed were for device performance and usability by professionals and lay users.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this is a visual qualitative immunochromatographic assay, not an algorithm-only device. Its performance is human-in-the-loop, as the results are visually interpreted. The "standalone" performance closest to this concept is the analytical performance studies (precision, sensitivity, specificity) which characterize the inherent chemical and biological function of the test strip/cassette/midstream.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Analytical Performance (Precision, Sensitivity, Specificity, Interference, etc.): Known concentrations of spiked hCG and interfering substances, determined by immunoassay (ELISA) or reference standards (e.g., WHO IS for hCG and hormones). This is a form of analytical reference method or objective known values.
- Professional Method Comparison: Comparison against a legally marketed predicate device.
- Lay User Method Comparison: Comparison against professional readings of the candidate device (which itself was compared to a predicate) or professional readings of masked spiked samples with known concentrations.
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The sample size for the training set:
- This document describes performance evaluation studies for a rapid diagnostic test, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The device's design is based on chemical and biological principles.
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How the ground truth for the training set was established:
- As there is no training set for an AI/ML model, 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.