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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).

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.

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Wondfo One Step HCG Urine Pregnancy Test Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (bCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. Important note regarding negative results: Some pregnant women will not be able to detect hCG in their urine 5 days before the expected period. If you test negative before your missed period, but think you may still be pregnant, you should test again a few days after your missed period. Important note regarding positive results: Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care. This product is intended for both prescription use and over-the-counter use.

Wondfo One Step HCG Urine Pregnancy Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. Important note regarding negative results: Some pregnant women will not be able to detect hCG in their urine 5 days before the expected period. If you test negative before your missed period, but think you may still be pregnant, you should test again a few days after your missed period. Important note regarding positive results: Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care. This product is intended for both prescription use and over-the-counter use.

Wondfo One Step HCG Urine Pregnancy Test Midstream is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. Important note regarding negative results: Some pregnant women will not be able to detect hCG in their urine 5 days before the expected period. If you test negative before your missed period, but think you may still be pregnant, you should test again a few days after your missed period. Important note regarding positive results: Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care. This product is intended for over-the-counter use.

Each of the devices (strip, cassette, and midstream) contains a pouch with the test and instructions. The cassette and midstream nitrocellulose test strips are contained in plastic housing. The cassette test also contains a dropper. The strips of each device contain mouse monoclonal anti-β-hCG antibody colloidal gold conjugate pre-dried on the pad, mouse monoclonal anti-u-hCG antibody (on the Test Line) and goat anti mouse IgG polyclonal antibody (on the Control Line).

Here's a breakdown of the acceptance criteria and study details for the Wondfo One Step HCG Urine Pregnancy Test, as extracted from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabulated format with pass/fail marks. However, it presents the performance characteristics measured and the results obtained for the device. Based on the information provided, we can infer the performance criteria and the device's reported performance:

• 7.5 mIU/mL: ~28-30% positive across formats and lots.
• 8 mIU/mL: ~50-51.7% positive across formats and lots.
• 9 mIU/mL: ~88.3-90% positive across formats and lots.
• 10 mIU/mL and above: 100% positive across formats and lots. |
  | Stability: Maintain performance over time. | Stable at 4-30°C for 24 months (based on accelerated stability at 50°C and real-time stability at 4°C and 30°C). |
  | Specificity and Cross-Reactivity: No interference from high hCG concentrations (no hook effect), different hCG fragments (B-core), or other glycoprotein hormones (LH, FSH, TSH). | High Dose Effect: No hook effect observed at hCG concentrations ranging from 6,250 to 200,000 mIU/mL.
  Effects of hCG ß-core fragment: No interference observed for urine samples with 0 mIU/mL hCG and 10 mIU/mL hCG (except false negative at 500,000 pmol/L of ß-core fragment hCG, which is a very high concentration).
  Effects of glycoprotein LH, FSH and TSH: No interference observed at LH concentrations up to 500 IU/mL, FSH concentrations up to 1000 mIU/mL, and TSH concentrations up to 1000 µIU/mL. |
  | Interfering Substances: No interference from various common substances. | No interference observed for all 20 tested compounds (Acetaminophen, Acetylsalicylic acid, Ascorbic acid, Atropine, Caffeine, Gentisic acid, Glucose, Hemoglobin, Tetracycline, Ampicillin, Albumin, B-hydroxybutyrate, Ephedrine, Phenylpropanolamine, Phenothiazine, EDTA, Salicyclic Acid, Benzoylecgonine, Cannabinol, Codeine, Ethanol, Bilirubin, Atropine, Pregnanediol, Thiophene, Ketone) at stated concentrations, for both 0, 10, and 100 mIU/mL hCG samples. |
  | Effect of Urine Specific Gravity and Urine pH: Consistent performance across varying urine properties. | No interference from pH ranging from 4 to 9.
  No interference from specific gravity ranging from 1.000 to 1.035. |
  | Precision: Consistent results across multiple replicates, operators, and lots. | Consistent results across 10 replicates for 5 consecutive days by three different operators at 3 POC sites, using 3 different lots for each format, for hCG concentrations ranging from 0 to 50 mIU/mL. E.g., for 10 mIU/mL, all 50 replicates were positive across all 3 lots for all formats. For 0, 2.5, 5 mIU/mL, all 50 replicates were negative across all 3 lots for all formats. The detection rates for 7.5 mIU/mL and 8 mIU/mL show expected variability around the cut-off. |
  | Method Comparison with Predicate Device: High agreement with a legally marketed predicate device. | 100% agreement for both positive and negative samples when compared to the FIRST RESPONSE™ Early Result Pregnancy Test (K123436) for all three device formats (Strip, Cassette, Midstream). |
  | Lay Person Study: Ease of use and accuracy when used by intended lay users. | Overall Agreement with Professional:
• Strip: 100% agreement (49+/51- vs 49+/51-).
• Cassette: 99% agreement (48+/51- vs 48+/52-), with 1 false positive by lay person.
• Midstream: 100% agreement (49+/51- vs 49+/51-).
  Correctness for Spiked Samples (5mIU/ml, 10mIU/ml):
• Strip: 99% for 5mIU/ml (1+/99-), 100% for 10mIU/ml (100+/0-). (Note: The table on page 13 for strips and 5 mIU/mL seems to have a typo, showing 1 positive for 5mIU/mL. The overall result for lay person vs professional for strips is 100% agreement, which contradicts the 1 positive result for 5mIU/mL in the next table. Assuming the professional comparison is the primary indicator of overall accuracy vs ground truth).
• Cassette: 100% for 5mIU/ml (0+/100-), 100% for 10mIU/ml (100+/0-).
• Midstream: 100% for 5mIU/ml (0+/100-), 99% for 10mIU/ml (99+/1-).
  Consistency for Spiked Samples (7.5mIU/mL, 8mIU/mL):
• Strip: 96% and 97%.
• Cassette: 96% and 96%.
• Midstream: 96% and 97%.
  Ease of Use: All lay users indicated instructions were easily followed. Flesch-Kincaid reading Grade Level of 7 for package inserts. |
  | False Positive Rate: Low rate of positive results in non-pregnant individuals. | Strip: 0.3% false positive results (1 false positive out of 300 non-pregnant females, from a peri-menopausal woman confirmed non-pregnant via ultrasound).
  Cassette: 0.3% false positive results (1 false positive out of 300 non-pregnant females, from a peri-menopausal woman confirmed non-pregnant via ultrasound).
  Midstream: 0% false positive results (0 out of 300 non-pregnant females). |
  | Early Pregnancy Detection: Ability to detect pregnancy early relative to the Expected Menstrual Period (EMP). | Detects:
• 68% positive hCG five days before EMP.
• 100% positive hCG on the day of EMP.
• Performance consistent across device formats. |
  | Substantial Equivalence: Overall performance comparable to the predicate device. | Concluded to be substantially equivalent to the predicate device (Church & Dwight Co., Inc. FIRST RESPONSE™ Early Result Pregnancy Test). |

2. Sample Size Used for the Test Set and Data Provenance

• Analytical Performance (Sensitivity/Cut-Off, Interference, Precision):
  • Sensitivity/Cut-Off: 20 replicates per hCG concentration level per lot (3 lots), tested by 12 operators. This means 60 tests per hCG level per format (e.g., for Strip format: 60 tests for 0mIU/ml, 60 for 5mIU/ml, etc.). The study used Urine standards containing intact hCG calibrated against WHO 4th IS for hCG. The provenance is not explicitly stated but is implied to be laboratory-prepared standards.
  • Specificity & Cross-reactivity: Samples (negative urine and 10 mIU/mL hCG) spiked with specified interfering substances. Each spiked sample was tested by 3 different lots and 3 different operators. The exact number of replicates per sample/condition is not explicitly stated, but for each interfering substance, a series of tests were done to ensure no interference.
  • Precision: 10 replicates per day for 5 consecutive days using 3 different lots for each format. This means 50 tests per hCG concentration per lot per format (e.g., for Strip format, 50 tests for 0mIU/ml, 50 for 2.5mIU/ml, up to 50 for 50mIU/ml, for each of the 3 lots). Tests were performed by 9 POC operators (3 for each format). The ground truth was negative human urine samples spiked with varying hCG concentrations (commercially available and traceable to 4th WHO international standard). Provenance is likely laboratory-prepared.
• Method Comparison with Predicate Device:
  • Sample Size: 100 urine samples for each format (total 300 samples).
  • Provenance: Collected from 100 women (about half pregnant, early stage at less than 5 weeks). Samples randomly collected at various times throughout the day. Ages ranged from 20 to 45 years. The provenance is clinical/human samples, seemingly prospective (collected for this study given the blind labeling and specific testing procedure). Country of origin is not specified.
• Lay Person Study:
  • Sample Size: 100 lay persons for the strip devices, 100 for the cassette devices, and 100 for the midstream devices (total 300 lay persons).
  • Provenance: For samples with known hCG concentrations, urine samples were prepared at 5mIU/ml, 8.0mIU/ml, 8.0mIU/ml hCG by spiking hCG into negative pooled urine specimens (laboratory-prepared). Additionally, each participant tested "her own urine sample" (clinical/human, self-collected). Provenance for lay users is diverse educational and professional backgrounds, aged 21 to >50 years, likely within the location of the study (not specified).
• False Positive Rate Study:
  • Sample Size: 300 non-pregnant females for strip, 300 for cassette, and 300 for midstream (total 900 non-pregnant female tests).
  • Provenance: Non-pregnant females who tested "their own urine samples" (clinical/human, self-collected). Provenance likely within the location of the study (not specified).
• Early Pregnancy Test Study:
  • Sample Size: 585 urine samples from 65 characterized cycle segments of conceptive cycles were collected from 65 pregnant women.
  • Provenance: Clinical/human samples from pregnant women.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Analytical Performance:
  • Sensitivity/Cut-Off: 12 operators tested each standard. Qualifications not specified, but likely laboratory technicians given the nature of the testing.
  • Specificity & Cross-reactivity: 3 different operators. Qualifications not specified, but likely laboratory technicians.
  • Precision: 9 Point-of-Care (POC) operators (3 different operators for each of 3 formats). Qualifications not specified, but suggests healthcare professionals.
• Method Comparison with Predicate Device:
  • Ground Truth: The "predicate device" serves as the reference standard.
  • Testing Personnel: 9 POC operators (three different health professionals at each of the 3 POC sites). Qualifications of "health professionals" not specified but implies skilled personnel.
• Lay Person Study:
  • Ground Truth: Professional testing of the same samples.
  • Testing Personnel: "Professional" testing results are compared to lay person results. The qualifications of these professionals are not explicitly stated, but it is implied they are trained individuals capable of accurately interpreting the test results.
• False Positive Rate Study:
  • Ground Truth: Derived from professional testing and, in some cases, ultrasound scan confirmation for the false positive results.
  • Testing Personnel: The results were from the non-pregnant females themselves, but the ground truth was also established by professional testing and, for the identified false positives, confirmed by ultrasound.
• Early Pregnancy Test Study:
  • Ground Truth: "Characterized cycle segments of conceptive cycles" from pregnant women indicate clinical diagnosis of pregnancy (likely through follow-up serum hCG, ultrasound, or confirmed delivery/outcome).
  • Testing Personnel: Tests were done by an unspecified number of individuals using all three formats. Implicitly, clinical professionals would have characterized the cycle segments.

4. Adjudication Method for the Test Set

The document does not explicitly describe a formal adjudication (e.g., 2+1, 3+1) method for conflicting interpretations of test results within the studies. Observations:

• Analytical Performance (Sensitivity/Cut-Off, Interference, Precision): For the sensitivity/cut-off and precision studies, results are reported as aggregates from multiple tests by multiple operators. It appears individual operator results were combined (e.g., 10-/10+ implies 10 negative, 10 positive results out of 20 by various operators). There's no mention of a consensus process for discrepant results at the individual reading level.
• Method Comparison and Lay Person Studies: These studies compare the device results to either a predicate device or professional results. The "Professional" results are presented as a single ground truth, implying any potential disagreements among professionals for the ground truth were already resolved or not present.
• False Positive Rate Study: For the two cases of false positives, an ultrasound scan was used for confirmation, which serves as a higher-level adjudication for those specific ambiguous cases.

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

An MRMC comparative effectiveness study was not performed in the context of AI assistance. This document describes a medical device (pregnancy test strips/cassettes/midstream) that is a rapid chromatographic immunoassay, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable, as the device is a manual, qualitative immunoassay. There is no algorithm or AI component. The user (human-in-the-loop) visually interprets the results.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The type of ground truth varied by study:

• Analytical Performance:
  • Sensitivity/Cut-Off, Specificity, Interfering Substances, Precision, Urine Properties: Laboratory-prepared hCG standards (calibrated against WHO 4th IS for hCG) in negative urine pools, or negative urine samples spiked with known substances. This represents a highly controlled and quantitative ground truth.
• Method Comparison with Predicate Device:
  • The predicate device (FIRST RESPONSE™ Early Result Pregnancy Test) served as the comparative ground truth.
• Lay Person Study:
  • Professional testing results of the same samples. For samples with known hCG concentrations, the prepared hCG concentrations served as ground truth.
• False Positive Rate Study:
  • Confirmed non-pregnancy status (e.g., patient history, and in specific false positive cases, confirmed by ultrasound scan).
• Early Pregnancy Test Study:
  • Characterized conceptive cycles from pregnant women. This implies clinical confirmation of pregnancy based on biological outcomes (i.e., actual pregnancy).

8. The Sample Size for the Training Set

This document describes performance studies for an existing medical device, not the development or training of an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The studies described are validation and verification studies for the device's performance.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI algorithm, this question is not applicable.

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EGENS One Step HCG Urine Pregnancy Test Kit (Strip) is a rapid chromatographic immunoassay for the qualitative detection of Human Chorionin (HCG) in urine samples to aid in the early detection of pregnancy by both professional and home users.

EGENS One Step HCG Urine Pregnancy Test Kit (Cassette) is a rapid chromatographic immunoassay for the qualitative detection of Human Chorionic Gonadotrophin (HCG) in urine samples to aid in the early detection of pregnancy by both professional and home users.

EGENS One Step HCG Urine Pregnancy Test Kit (Midstream I) is a rapid chromatographic immunoassay for the qualitative detection of Human Choric Gonadotrophin (HCG) in urine samples to aid in the early detection of pregnancy by home users.

EGENS One Step HCG Urine Pregnancy Test Kit (Midstream II) is a rapid chromatographic immunoassay for the qualitative detection of Human Chorionic Gonadotrophin (HCG) in urine samples to aid in the early detection of pregnancy by home users.

One Step HCG Urine Pregnancy Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine for the early detection of pregnancy. HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. This test is capable of detecting pregnancy the first day after a missed period. As pregnancy progresses, higher levels of HCG are present in urine at concentrations of 25mlU/ml (Milli-International Units) or greater. The concentration of HCG in non-pregnant women is normally 5.0mlU/ml. At the time of the last missed menstrual period, urine HCG levels are about 100mlU/ml with peak levels of 100,000 to 200,000mlU/ml. The test devices are in four different formats: Strip, Cassette, Midstream I , and Midstream II .

The HCG assay is a rapid one-step test based on immunochromatographic technology. This device is composed of glass fiber strips of the monoclonal antibody against HCG, anti-mouse IgG, solid cellulose nitrate membrane, and the bonders of absorptive colloidal gold - monoclonal antibody against HCG. It adopts the principles of the double antibody sandwich method and imunochromatography technology to test for the presence of HCG in urine.

This document describes a regulatory submission (K123050) for the EGENS One Step HCG Urine Pregnancy Test Kit. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.

The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies against explicitly defined acceptance criteria as might be found in a clinical trial report or a standalone performance study.

Here's a breakdown of why this information is largely absent from the provided text, and what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative targets. The "Cut Off Values" are 25 mIU/mL, which is a key performance parameter, but not an "acceptance criterion" for a study.
• Reported Device Performance: Not provided in the form of sensitivity, specificity, accuracy, or other metrics from a clinical study. The document states that the EGENS kits "have similar technological characteristics and performances to the predicate," but no specific performance data is presented.

2. Sample Size for Test Set and Data Provenance:

• This information is not provided in the document. Substantial equivalence claims often rely on analytical performance comparisons and equivalence in design and intended use, rather than extensive clinical efficacy studies, especially for well-established diagnostic categories like HCG tests.

3. Number of Experts and Qualifications:

• This information is not applicable/not provided. The document is a regulatory submission for a medical device cleared via the 510(k) pathway, which typically does not involve human expert adjudication of results in the way, for example, an imaging AI system might.

4. Adjudication Method:

• Not applicable/not provided for the reasons stated above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, this was not done. MRMC studies are typically for complex diagnostic tasks often involving human interpretation (e.g., radiology, pathology) where AI assistance can be quantitatively measured. This device is a simple, qualitative immunoassay.

6. Standalone (Algorithm Only) Performance Study:

• The device itself is a standalone test. However, the document does not present a formal "standalone performance study" report with metrics like sensitivity, specificity, etc. It simply describes the device's function and claims substantial equivalence. The analytical performance (e.g., limit of detection, cross-reactivity) would have been assessed by the manufacturer as part of their design validation, but these detailed results are not in this public summary.

7. Type of Ground Truth Used:

• Inferred: The ground truth for HCG tests is typically established by using known concentrations of HCG (e.g., from WHO International Standard 3rd Edition as mentioned for traceability) in urine samples, and possibly clinical correlation with documented pregnancies or absence thereof. However, the document does not explicitly state how ground truth was established for any performance evaluation.

8. Sample Size for Training Set:

• Not applicable/not provided. This device is a biochemical immunoassay, not an AI/machine learning algorithm that requires a "training set."

9. How Ground Truth for Training Set was Established:

• Not applicable/not provided for the same reasons as #8.

Summary Table (Based on what can be extracted or inferred, and explicitly noting what is missing):

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IND One Step hCG Urine Pregnancy Tests Device is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine to help in the early determination of pregnancy. The device is designed for over-the-counter use.

Not Found

The provided text does not contain information about acceptance criteria or a study proving the device meets them. It is an FDA 510(k) clearance letter for the "IND One Step hCG Urine Pregnancy Test (Strip)", indicating that the device has been found substantially equivalent to legally marketed predicate devices.

The letter does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes, data provenance, or ground truth establishment for any test sets.
• Information regarding expert involvement, adjudication methods, or MRMC studies.
• A description of standalone algorithm performance.
• Sample size or ground truth methods for a training set.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided document. The document is solely an FDA clearance letter affirming substantial equivalence for marketing.

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Ask a specific question about this device

The Guangzhou Wondfo Biotech Co., Ltd. One Step HCG Urine Pregnancy Test is intended for non-professional, over-the-counter use and for professional and laboratory use for the qualitative determination of elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.

The One Step HCG Urine Pregnancy Test is intended for use by professional healthcare personnel trained in its use and for Over-the-Counter use.

The device consists of a single test strip with one end designated for dipping, and control and test regions in the middle. At one end of the sample pad there is a line with arrows indicating which end of the strip should not be dipped below this line.

The One Step HCG Urine Pregnancy Test device is similar in design, materials and performance to other legally marketed "home pregnancy test devices" that are in commercial distribution.

Here's a breakdown of the acceptance criteria and study information for the One Step HCG Urine Pregnancy Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria in terms of numerical performance targets (e.g., sensitivity, specificity, accuracy against a gold standard). Instead, the 510(k) summary focuses on demonstrating substantial equivalence to predicate devices. This means the device is considered acceptable if its performance is comparable to already legally marketed devices.

However, based on the nature of a pregnancy test, the implied acceptance criteria would revolve around the accurate detection of HCG. The "reported device performance" in this context refers to the successful demonstration of performance similar to predicate devices, which allowed for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for performance studies. The 510(k) summary primarily focuses on regulatory equivalence rather than detailed clinical study results in this document.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided text does not mention the number of experts used or their qualifications for establishing ground truth in any performance study. This type of detail is typically found in the full study report, which is not included here.

4. Adjudication Method

The provided text does not mention any adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed or reported in this document. The focus is on the device's standalone performance in comparison to predicate devices, not on human reader performance with or without AI assistance. The device is a "One Step HCG Urine Pregnancy Test," implying a direct read of a test line, not an AI-assisted diagnostic.

6. Standalone (Algorithm Only) Performance Study

As this is a chemical/biochemical diagnostic test (HCG urine test) and not an AI-driven device, the concept of a "standalone (algorithm only)" performance study does not apply. The device itself is the "standalone" entity that performs the detection. The 510(k) process for such devices relies on demonstrating the accuracy of the chemical reaction and visual interpretation.

7. Type of Ground Truth Used

The type of ground truth used to evaluate the performance of this device would typically involve a reference laboratory method for detecting HCG, such as a quantitative blood HCG test or another highly accurate and validated urine HCG test method. The provided text does not explicitly state the specific ground truth method used in any underlying studies, but it is implied to be related to the "quantification" or "detection" of hCG.

8. Sample Size for the Training Set

The provided text does not mention any training set sample size. As this is a chemical diagnostic test that works based on a fixed biochemical reaction, there is no "training set" in the machine learning sense. The device's design and materials are optimized through development, not by training an algorithm on a data set.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" in the context of an algorithm for this device, the question of how its ground truth was established does not apply. The performance of the test relies on the inherent chemical properties and design, which are validated against known HCG concentrations and clinical samples in studies.

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