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Innovita HCG Pregnancy Rapid Combo Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy. The test is for health care professionals use including professionals at point of care (POC).

The Innovita HCG Pregnancy Rapid Combo Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine or serum for the early detection of pregnancy. During pregnancy, HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test device is used as a single cassette device.

The provided text describes the performance characteristics of the Innovita HCG Pregnancy Rapid Combo Test, a rapid chromatographic immunoassay for qualitative detection of human chorionic gonadotropin (HCG) in urine or serum to aid in early detection of pregnancy.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The "Acceptance Criteria" for this device are implicitly tied to its performance characteristics, aiming to demonstrate substantial equivalence to a legally marketed predicate device (K203272, Alltest Pregnancy Rapid Combo Test Cassette). The document doesn't explicitly list "acceptance criteria" as pass/fail thresholds in a formal table, but rather presents the results of various analytical studies that collectively support the device's accuracy, precision, and reliability.

However, based on the performance data presented, here's a table summarizing the implicit criteria and the reported performance:

2. Sample Sizes and Data Provenance

• Test Set Sample Size:

  • Precision/Reproducibility/Cut-Off Value Study: For each HCG concentration, 6 replicates per day for 5 days, using 3 different lots, across 3 testing sites. This totals 90 individual tests per concentration (6 replicates * 5 days * 3 lots = 90). The number of unique samples (negative serum/urine spiked with HCG) is not explicitly stated beyond "Negative serum or urine specimens from females were spiked with varying HCG concentrations."
  • High Dose Effect Study: Spiked samples tested by 3 different lots and 3 different operators. The exact number of replicate tests is not specified, but multiple concentrations were tested.
  • Effects of hCG ß-core fragment, LH, FSH, TSH interference studies: Samples tested by 3 different lots and 3 different operators. Number of replicates not specified.
  • Interference from Common Exogenous Compounds: Each spiked sample tested using 3 different lots; number of replicates per lot not specified.
  • Effect of Urine Specific Gravity and Urine pH: Tested using 3 different lots by 3 different operators; number of replicates not specified.
  • Method Comparison Study: 108 urine samples and 102 serum samples from 210 women.

• Data Provenance:

  • No specific country of origin is mentioned for the clinical samples. The submitter is INNOVITA (Tangshan) Biological Technology Co., Ltd. in China, and the contact person is in the USA.
  • The method comparison study states: "108 urine and 102 serum samples were collected from 210 women... from three testing sites." The study is described as "A method comparison study was performed," suggesting a prospective collection of samples for the purpose of the study, rather than retrospective. The samples were from "women expecting to be pregnant, early stage at less than 5 weeks."

3. Number of Experts and Qualifications for Ground Truth

• The document states that for the Precision/Reproducibility study, tests were performed by six different operators for each sample concentration across three sites, and the interference studies were performed by three different operators.
• The "Method Comparison Study" states: "Samples were tested by different health professionals with the proposed and the predicate devices at each site."
• Qualifications of these "operators" or "health professionals" are not specified beyond their role in performing the tests. No mention is made of "experts" specifically establishing a ground truth through consensus in the studies described.
• The ground truth for the analytical studies (precision, cut-off, interference) was established by the known concentrations of spiked HCG (traceable to the 5th WHO international Standard).
• For the comparative study, the "ground truth" was essentially the result of the predicate device (K203272). The study aims to show agreement with the predicate, not necessarily against an independent clinical "true" state confirmed by external means like pathology or clinical outcomes.

4. Adjudication Method for the Test Set

• For the analytical studies (precision, cut-off, interference), the "ground truth" was the known spiked concentration of HCG. The "adjudication" was the comparison of the device's result ("-" or "+") against this known concentration. There's no mention of an expert adjudication process in this context, as results are quantitative comparisons to predefined levels.
• For the Method Comparison Study, the document states "The study result shows 100% agreement for all samples to the predicate device." This implies a direct comparison of the new device's result to the predicate device's result for each sample. There's no indication of an adjudication method (e.g., 2+1 or 3+1 expert review) for resolving discrepancies, as presumably, there were no discrepancies ("100% agreement").

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

• No, an MRMC comparative effectiveness study, as typically understood for evaluating AI-assisted workflows in diagnostic imaging, was not performed. This device is a rapid diagnostic test kit, not an AI or imaging device that assists human readers.
• The comparison study was between the new device and a predicate device, both read by "different health professionals." The effectiveness is measured by agreement between the devices, not by human reader performance improvement with/without AI assistance.

6. Standalone (Algorithm Only) Performance

• This question is not applicable to this device. The Innovita HCG Pregnancy Rapid Combo Test is a lateral flow immunoassay cassette, not a software algorithm or an AI system that would have a "standalone" algorithmic performance. Its performance is intrinsically linked to the physical test kit's chemical reactions and visual interpretation.

7. Type of Ground Truth Used

• For the analytical performance studies (precision, cut-off, high dose, specificity, interference, pH/SG): The ground truth was analytical truth based on known, precisely controlled concentrations of HCG (traceable to WHO international standard) and interferents spiked into negative or known positive samples.
• For the method comparison study: The ground truth was effectively the results obtained from the legally marketed predicate device (K203272). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices. No pathology or long-term clinical outcome data was used as ground truth for this submission.

8. Sample Size for the Training Set

• Not applicable / Not explicitly stated. This is a rapid diagnostic test kit, not a machine learning model that typically requires a large "training set" of data. The "training" of such a device is in its chemical and biological design and manufacturing process, not in data-driven algorithmic learning.

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

• Not applicable. As above, there's no "training set" in the context of an AI/ML device. The "ground truth" for developing and manufacturing such a chemical assay would involve rigorous quality control, calibration, and R&D studies based on established biological and chemical principles, likely using purified HCG standards and clinical samples. However, the document does not detail these developmental processes.

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The Altest Pregnancy Rapid Combo Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy. The test is for health care professionals use including professionals at point of care (POC).

The Alltest Pregnancy Rapid Combo Test Cassette measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine or serum for the early detection of pregnancy. During pregnancy, HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test device is used as a single cassette device.

The provided document is a 510(k) summary for the Alltest Pregnancy Rapid Combo Test Cassette, which is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum to aid in the early detection of pregnancy. The device is intended for prescription use by healthcare professionals, including those at the point of care.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a separate section with predefined thresholds. Instead, it presents performance data from various studies. Based on the "Performance Characteristics" section, the implicit acceptance criteria are that the device should demonstrate:

• High precision and accuracy around the cut-off values.
• Stability over an extended period.
• Specificity, with no significant interference from related hormones or common substances.
• No high-dose hook effect.
• Performance comparable to a legally marketed predicate device.

The reported device performance aligns with these implicit criteria, indicating successful validation.

• Urine: At 15 mIU/mL (below cut-off), 48.9% positive. At 17.5 mIU/mL (below cut-off), 80% positive. At 20 mIU/mL (cut-off), 100% positive. At 0, 5, 10 mIU/mL, 100% negative. At concentrations >= 20 mIU/mL, 100% positive.
• Conclusion: Cut-off values of 10 mIU/mL for serum and 20 mIU/mL for urine are verified. |
  | Stability | Demonstrate stability for an appropriate shelf life under specified storage conditions. | Stable at 2-30°C for 24 months based on an accelerated stability study at 55°C. |
  | Specificity (High Dose Effect) | No hook effect at high hCG concentrations. | No hook effect observed with hCG concentrations ranging from 500 to 2,000,000 mIU/mL. |
  | Specificity (ß-core fragment) | No significant interference from hCG ß-core fragment up to certain concentrations. | No interference observed except for false positives above 100 pmol/L ß-core fragment hCG. (Note: The document doesn't provide the expected range of ß-core fragment in actual samples or how this level of interference compares to clinical relevance, but states "No difference was observed for different lots and different operators.") |
  | Specificity (Glycoprotein Hormones) | No interference from LH, FSH, TSH at physiological/elevated levels. | No interference observed at LH concentrations up to 500 IU/mL, FSH concentrations up to 1000 mIU/mL, and TSH concentrations up to 1000 uIU/mL. |
  | Interference (Common Substances) | No interference from a specified list of common exogenous and endogenous substances at given concentrations. | All tested compounds (Acetaminophen, Acetoacetic Acid, Ascorbic Acid, Atropine, Acetosalicylic Acid, Albumin, Bilirubin, Caffeine, Codeine, Ephedrine, EDTA, Ethanol, Gentisic Acid, Glucose, Hemoglobin, Methadone, Phenylpropanolamine, Phenothiazine, Pregnanediol, Salicylic Acid, ß-hydroxybutyrate, Benzoylecgonine, Cannabinol, Methanol, Estriol-17-beta, Thiophene, Ampicillin, Tetracycline, Ketone, Total cholesterol, Triglycerides, High-density lipoprotein) showed no interference at the stated concentrations for both negative and positive hCG samples. |
  | Effect of Urine Specific Gravity & pH | No interference across physiological/pathological ranges of urine specific gravity and pH. | No interference from pH ranging from 4 to 9 and specific gravity ranging from 1.001 to 1.035. |
  | Method Comparison | Demonstrate substantial equivalence (high agreement) with a legally marketed predicate device. | * Urine: 100% agreement between the new device and the predicate (53 positive, 52 negative).
• Serum: 100% agreement between the new device and the predicate (58 positive, 49 negative). |

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

• Precision/Reproducibility/Cut-Off Value Study:

  • Test Set Size (Serum): 90 replicates for each hCG concentration level (3 sites x 30 replicates per concentration). In total, 9 concentrations were tested, so 90 x 9 = 810 tests.
  • Test Set Size (Urine): 90 replicates for each hCG concentration level (3 sites x 30 replicates per concentration). In total, 9 concentrations were tested, so 90 x 9 = 810 tests.
  • Data Provenance: Not explicitly stated, but the testing was conducted at "three testing sites" by "six different operators." It's likely these were internal or contract labs, possibly within China (where the manufacturer is located) or the US (where the submitter's contact is). The data is from controlled experimental studies.
  • Retrospective/Prospective: Prospective (experimental spiking of samples).

• Method Comparison Study:

  • Test Set Size (Urine): 105 urine samples.
  • Test Set Size (Serum): 107 serum samples.
  • Total Test Set Size: 212 samples (from 212 women).
  • Data Provenance: Samples collected from 212 women from "three testing sites." Ages ranged from 20 to 49 years. "About half of them were pregnant, early stage at less than 5 weeks." Not explicitly stated, but implies clinical samples used for comparison. The country of origin is not specified.
  • Retrospective/Prospective: Likely prospective clinical sample collection for the purpose of the study.

• Other Analytical Performance Studies (Specificity, Interference, pH/Specific Gravity):

  • Sample sizes vary but generally involve spiking negative and positive samples with various concentrations of the interferent/condition and testing with 3 different lots by 3 different operators. Exact total sample counts for each condition are not explicitly provided but involve multiple replicates across lots and operators.
  • Data Provenance: Controlled experimental studies with spiked samples.
  • Retrospective/Prospective: Prospective (experimental spiking of samples).

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

• Precision/Reproducibility/Cut-Off Value Study: The "ground truth" for the test set was established by precisely spiking known concentrations of hCG (traceable to the 5th WHO international Standard) into negative serum or urine specimens. This is an analytical truth rather than an expert interpretation. Six different operators performed these tests; their qualifications are not specified but would typically be laboratory technicians.
• Method Comparison Study:
  • The "ground truth" for the comparison study was the result obtained from the predicate device (K132834, Clarity Diagnostics Clarity hCG Pregnancy Combo Test Cassette). This means the predicate device itself served as the reference standard, and the new device's agreement was measured against it.
  • There is no mention of independent experts establishing a "true" pregnancy status. The comparison is between two devices.
  • The tests were performed by "different health professionals," but their specific number or qualifications (e.g., radiologist with 10 years of experience) are not provided.

4. Adjudication Method for the Test Set

• Precision/Reproducibility/Cut-Off Value Study: No adjudication method as the ground truth was analytically determined (spiked concentrations). Results were recorded and analyzed statistically.
• Method Comparison Study: No adjudication method mentioned for comparing the predicate and new device results against a separate "true" outcome. The comparison itself uses the predicate device as the reference.

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

No. This document describes the performance of an in-vitro diagnostic (IVD) test, not an imaging device or AI-powered diagnostic that would typically involve human readers interpreting cases with and without AI assistance. Therefore, an MRMC comparative effectiveness study was not performed, and there is no effect size reported for human readers improving with AI vs. without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in essence. The studies present the analytical performance of the device itself (the "algorithm" or immunoassay), reporting its ability to detect hCG in various conditions. While "health professionals" perform the tests, the core performance characteristics (sensitivity, specificity, cut-off accuracy, interference) are inherent to the device's design and chemical reactions, operating in a standalone manner once the sample is applied. The "Method Comparison Study" directly evaluates the standalone performance of the device against another device.

7. Type of Ground Truth Used

• Analytical Studies (Precision, Specificity, Interference, pH/Specific Gravity): The ground truth was based on known, precisely controlled concentrations of hCG, interferents, or specific pH/gravity conditions, established through spiking or preparing samples. This is a form of analytical truth.
• Method Comparison Study: The ground truth for this study was the results obtained from a legally marketed predicate device. The predicate device's results were accepted as the reference against which the new device was compared.

8. Sample Size for the Training Set

This document primarily describes analytical validation and comparison studies. For an IVD device like this, there isn't typically a "training set" in the machine learning sense. The device's performance is driven by its biochemical design and manufacturing process, not trained on data. Development may involve iterative testing and refinement, but a formal "training set" size as understood in AI/ML is not applicable or provided here.

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

As noted above, a "training set" in the context of AI/ML is not applicable for this type of immunoassay device. The device's operational parameters (like antibody conjugates, membrane properties, and cut-off thresholds) are established through research, development, and analytical validation studies, not by training on a labeled dataset.

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The Atellica IM Total hCG (ThCG) assay is for in vitro diagnostic use in the quantitative determination of human chorionic gonadotropin (hCG) in human serum using the Atellica IM Analyzer. The Atellica IM ThCG assay is intended for use as an aid in the early detection of pregnancy.

The Atellica IM Total hCG (ThCG) assay is an in vitro diagnostic assay for the quantitative determination of human chorionic gonadotropin (hCG) in human serum using the Atellica IM Analyzer. The assay utilizes a sandwich immunoassay principle with direct chemiluminescent technology. The reagents include a Lite Reagent containing goat polyclonal anti-hCG antibody labeled with acridinium ester and a Solid Phase containing mouse monoclonal anti-hCG antibody covalently coupled to paramagnetic particles. Ancillary reagents like Atellica IM ThCG DIL are also part of the system.

The Siemens Atellica IM Total hCG (ThCG) assay is an in vitro diagnostic device for the quantitative determination of human chorionic gonadotropin (hCG) in human serum, intended as an aid in the early detection of pregnancy.

Here's an analysis of its acceptance criteria and the study that proves its performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document outlines several performance characteristics, including detection capability, precision, and method comparison, against a predicate device (ADVIA Centaur Total hCG assay).

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

• Detection Capability (LoD): 601 determinations, with 300 blank and 301 low-level replicates. The document doesn't specify data provenance (country of origin or retrospective/prospective).
• Detection Capability (LoQ): Multiple samples prepared from the World Health Organization (WHO) human chorionic gonadotropin reference material (NIBSC code: 99/688). No specific sample count is given for the test set, but it implies a study on prepared samples. Data provenance is implied to be laboratory-based and controlled using a recognized international standard.
• Precision: Not a "test set" from patients, but rather control materials and serum pools. Samples were assayed in duplicate in 2 runs per day for 20 days using two reagent lots on each of two Atellica IM analyzers, leading to 320 data points for each serum pool and control (2 duplicates * 2 runs/day * 20 days * 2 analyzers * 1 sample type / 2 for reagent lots = 320 for each condition)
• Method Comparison: 115 serum specimens. The data provenance (country of origin, retrospective or prospective) is not specified.
• Interference: "Serum samples" used, concentrations given, but no specific number of unique patient samples mentioned.
• Expected Values: 366 serum samples from 192 apparently healthy non-pregnant females and 174 apparently healthy postmenopausal females. The provenance is not specified. This appears to be a prospective collection for establishing reference ranges.

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

This information is not applicable as the Atellica IM Total hCG assay is a quantitative diagnostic test for a biomarker (hCG) in serum. The 'ground truth' for such assays is typically established by:

• Reference Methods: Highly accurate and precise laboratory methods.
• Certified Reference Materials: Materials with an assigned value from an authoritative source (like the WHO reference material mentioned for LoQ).
• Clinical Diagnosis: For outcomes like pregnancy, a clinical diagnosis confirms the state, and the device then quantifies the biomarker associated with that state.

There is no mention of human experts establishing a 'ground truth' in the context of image interpretation or subjective diagnosis for this device.

4. Adjudication Method for the Test Set:

This is not applicable as the Atellica IM Total hCG assay is an automated quantitative assay. There is no subjective interpretation or need for adjudication by experts as would be found in image-based diagnostic systems.

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:

This is not applicable. The Atellica IM Total hCG assay is an automated in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting cases. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The performance studies described (detection capability, precision, method comparison, interference, expected values) represent the standalone performance of the Atellica IM Total hCG assay. This device is designed to provide quantitative results directly from serum samples through an automated analyzer, without direct human-in-the-loop interpretation that would alter the result. The device performance itself is evaluated.

7. The Type of Ground Truth Used:

• Detection Capability (LoD, LoQ): Determined using prepared samples traceable to the World Health Organization (WHO) 4th International Standard (NIBSC code: 99/688) for human chorionic gonadotropin. This is a form of certified reference material ground truth.
• Precision: Internal serum pools and commercial controls with known concentrations served as the basis for evaluating reproducibility.
• Method Comparison: The ADVIA Centaur Total hCG assay (predicate device) served as the comparative reference, implying that its established measurements were the 'ground truth' for comparison, to show substantial equivalence.
• Interference: Spiked serum samples (serum with known amounts of hCG and interferents added) were used.
• Expected Values: Clinical classification of "non-pregnant females" and "postmenopausal females" served as the basis for establishing reference intervals. This aligns with clinical outcome/classification ground truth.

8. The Sample Size for the Training Set:

The document does not explicitly describe a "training set" in the context of machine learning or AI, as this is an immunoassay device. The studies described are performance validation studies. The calibration of the device (using Atellica IM CAL B) and the determination of its "master curve" can be thought of as akin to a training process for an assay, but no sample size for this is provided.

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

As mentioned, there isn't a "training set" in the AI/ML sense. The "ground truth" for the assay's operational parameters (like calibration and standardization) is established through:

• Standardization against the World Health Organization (WHO) 4th IS 75/589 reference material. This is a universally recognized standard, meaning calibrator values are traceable to this international reference.
• Two-point calibration using specific calibrators (Atellica IM CAL B) which themselves are assigned values traceable to the WHO standard.

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TrueDx™ hCG Early Result Pregnancy Test (Midstream & Cassette Formatographic immunoassay for qualitative detection of human chorionic (hCG) in urine, as an in aid in early detection of pregnancy, in some case 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.

VeriClear™ Early Result Pregnancy Test (Midstream & Cassette Formatographic immunoassay for qualitative detection of human chorionic (hCG) in urine, as an in aid in early detection of pregnancy, in some case 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.

TrueDX™ hCG Early Result Pregnancy Test is designed to be tested in midstream and cassette mode. Each of the devices (Cassette and Midstream), contains a pouch with the test and instructions for use. The cassette and midstream nitrocellulose test strips are contained in a plastic housing. The cassette test also contains a dropper.

TrueDX™ hCG Early Result Pregnancy Test is a qualitative lateral flow immunoassay for the detection of hCG. The device comes in two formats: Cassette and Midstream. Each device includes a pouch with the all components to perform the test, instruction for use and a desiccant package to control the moisture during the storage of the test kit. The cassette and midstream nitrocellulose test strips are mounted in a plastic housing. The cassette test, which is designed to be used as prescription use contains a dropper pipette.

The VeriClear™ Early Result Pregnancy Test and TrueDX™ hCG Early Result Pregnancy Test are the same devices, except the device names and intended use population.

The provided document is a 510(k) Summary for the TrueDX™ hCG Early Result Pregnancy Test and VeriClear™ Early Result Pregnancy Test, which are qualitative chromatographic immunoassays for the detection of human chorionic gonadotropin (hCG) in urine. The document details the device's performance characteristics, including analytical and clinical studies.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied rather than explicitly stated as quantitative targets in a table within this summary document for certain aspects. However, for analytical sensitivity, a clear target is indicated. For other performance metrics, the "acceptance" is demonstrated by the reported results showing highly accurate and consistent performance, often achieving 100% agreement or detection at specified levels.

Here's a table summarizing the acceptance criteria (inferred or explicitly stated) and the reported device performance:

2. Sample sizes used for the test set and data provenance:

• Precision/Reproducibility:
  • Across Lots: 250 replicates per hCG level per lot (10 replicates/run x 5 operators x 5 days). Total of 750 replicates per hCG level for 3 lots.
  • Across Operators: 150 replicates per hCG level per operator (from the above dataset).
• Within-Lot Reproducibility: 20 replicates for each hCG level.
• Analytical Sensitivity: 15 replicates per hCG concentration per lot. Total of 45 replicates per hCG concentration for 3 lots.
• Analytical Specificity (Interference): At least 2 replicates (implied by "2 different lots") per substance for negative and 10 mIU/ml hCG samples. ("All samples were tested in replicates of 5 for each format" is also stated later, suggesting maybe 5 replicates per lot per sample type.)
• Cross-reactivity: Replicates for each substance (number not explicitly stated, but "tested by two operators with two lots of the test kit for each format" implies multiple tests). For hyper-glycosylated hCG, 5 replicates per hCG concentration for 3 different lots.
• pH/Specific Gravity/Hook Effect/β-core Fragment: Replicates tested (number not always explicitly stated, but implied as sufficient for robust testing). For hook effect, 3 lots tested by 2 operators.
• Method Comparison with Predicate Device: 166 urine samples from women at physician offices.
• Clinical Samples (Early Pregnancy Detection): 616 urine samples from 56 different women.
• Lay User Study:
  • Actual Urine: 218 females tested their own urine (110 Midstream, 108 Cassette). 9 pregnant, 101 non-pregnant for Midstream/Midstream-Dip; 6 pregnant, 102 non-pregnant for Cassette.
  • Spiked Urine: 53 samples at each hCG level for Midstream, 57 for Midstream-Dip, and 110 for Cassette.
• Specificity Study (False Positives in Non-Pregnant Women): 320 non-pregnant women (100 pre-menopausal, 111 peri-menopausal, 109 post-menopausal).

Data Provenance:
The document does not explicitly state the country of origin for the data. The studies are described as internal performance evaluations. While patient samples were collected from "physician offices" and "women who planned to become pregnant," the document doesn't specify if these were prospective or retrospective collections, though the early pregnancy detection study following women throughout their conception cycles sounds prospective for that specific cohort. The lay user study involved participants with diverse backgrounds recruited specifically for the study, suggesting a prospective design for that component.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

The document describes the device as measuring hCG levels, where hCG is a biological marker. Ground truth for hCG levels in urine samples for the analytical studies (precision, sensitivity, specificity) was established by spiking known concentrations of hCG standard traceable to the WHO 4th International Standard, or by using known negative urine samples. These are objective, quantitative measures rather than observer-dependent expert interpretations.

For the method comparison study, the predicate device was presumably used as the reference standard, and the results of both the candidate and predicate devices were compared. The text states "Urine samples were collected from 166 women at physician offices for pregnancy testing," and the samples were "masked and randomized." All samples were tested by "two different health care professionals." Their specific qualifications are not detailed beyond "health care professionals."

For the clinical sample (early pregnancy detection) study, samples were collected from women followed throughout their conception cycles. The ground truth for pregnancy status and relative timing to the expected menstrual period (EMP) would be clinical, likely based on confirmed pregnancy outcomes and menstrual cycle tracking. The document implies that the detection rate is against the true biological state rather than expert interpretation of the test result itself.

For the lay user study, professional users also tested aliquots of the same urine samples as a reference for comparison, implying their results served as a ground truth for interpretation consistency. Their qualifications are not specified beyond "professional."

For the specificity study to determine false-positive rates, an "ELISA quantitative analyzed hCG level test kit" was used as the reference method ("ground truth") to confirm hCG levels, and subjects with positive results on the new device or hCG levels >5.00 mIU/ml on ELISA were referred for "clinical confirmation of positive." This implies a multi-modal ground truth involving an objective lab assay and clinical follow-up.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication methods (like 2+1, 3+1 for consensus readings) are typically used in image-based AI studies where human interpretation is the primary ground truth. This is an hCG urine test kit.

• For analytical studies, the "ground truth" is the known spiked concentration or the characterized negative sample. No adjudication is needed as the result is objectively positive/negative based on the strip's reaction.
• For the precision study, multiple operators tested replicates, and the results were aggregated to calculate reproducibility (e.g., % positive). This is a statistical aggregation, not adjudication.
• For the method comparison study, each sample was tested by "two different health care professionals." It's not stated whether there was an adjudication rule if their interpretations differed; given it's a qualitative test (positive/negative), disagreements would likely be rare or require re-testing/third party confirmation. The 100% agreement reported suggests no significant discrepancies needed formal adjudication.
• For the lay user study, lay user results were compared to professional user results. Discrepancies (e.g., 8 lay users positive vs. 9 professional positive for 7.0mIU/ml, or 30 vs 32 for 8.5mIU/ml) are simply reported as the difference in numbers/percentages, indicating performance deviation, not an adjudication process to force agreement.

Therefore, formal adjudication as typically understood in reader studies was not applicable or explicitly described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size:

No, an MRMC study was not done. MRMC studies are primarily for evaluating the impact of AI on human reader performance in diagnostic imaging by measuring reader accuracy with and without AI assistance across multiple cases and readers. This document describes a standalone in-vitro diagnostic (IVD) test kit, not an AI-powered diagnostic tool for human interpretation.

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

Yes, the device is inherently a standalone chemical assay that produces a visual result. The various analytical and clinical studies described (precision, sensitivity, specificity, early pregnancy detection with clinical samples, false-positive rate) demonstrate the "algorithm only" performance (i.e., the device's performance as an assay) without human-in-the-loop assistance influencing the outcome of the test itself. The lay user study primarily evaluates ease of use and interpretation accuracy by lay users rather than an assisted vs. unassisted performance comparison.

7. The type of ground truth used:

• Analytical Studies (Precision, Sensitivity, Specificity): Primarily known spiked concentrations of hCG standard (traceable to WHO 4th International Standard) in negative human urine, and characterized negative urine samples. This is a form of reference standard/laboratory-defined ground truth.
• Method Comparison: Comparison against a legally marketed predicate device (FIRST RESPONSE Early Result Pregnancy Test) on collected urine samples. The predicate device's result serves as the de-facto ground truth for equivalence.
• Early Pregnancy Detection Clinical Samples: Likely clinical confirmation of pregnancy (e.g., blood tests, ultrasound, follow-up) and menstrual cycle tracking for timing relative to the expected period. This is based on outcomes data/clinical truth.
• Lay User Study: Comparison against results obtained by professional users testing aliquots of the same samples (both actual and spiked urine). This is a consensus or expert interpretation ground truth for comparing interpretational consistency.
• Specificity Study (False Positives in Non-Pregnant Women): Quantitative ELISA hCG level test kit results and subsequent clinical confirmation for any elevated hCG or positive results. This combines a laboratory assay ground truth with clinical confirmation/outcomes data.

8. The sample size for the training set:

This document describes a 510(k) submission for a traditional in-vitro diagnostic test kit (lateral flow immunoassay) based on chemical reactions and visual interpretation. It is not an AI/ML-based device, and therefore, there is no "training set" in the context of machine learning. The development of such a device involves iterative R&D, chemical formulation, and design, but not data-driven algorithmic training.

9. How the ground truth for the training set was established:

As there is no AI/ML training set, this question is not applicable to the described device.

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The Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy.

This product is intended for prescription use in clinical laboratories and point-of-care use settings.

The Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy.

This product is intended for prescription use in clinical laboratories and point-of-care use settings.

Assure Tech hCG Pregnancy Serum/Urine Combo Test (Cassette, Strip) measures the presence of the hormone Human Chorionic Gonadotrophin (hCG) in human urine or serum for the early detection of pregnancy. During pregnancy, hCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test devices are in two different formats: Strip, Cassette.

Here's an analysis of the acceptance criteria and study details for the Assure Tech hCG Pregnancy Serum/Urine Combo Test, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to its "precision/reproducibility/cut-off value" and "method comparison" studies. The goal is to perform accurately around the established cut-off values and show strong agreement with a predicate device.

Study Details

1. Sample Size and Data Provenance:
   • Test Set (Precision/Reproducibility): For each format (Serum Strip, Serum Cassette, Urine Strip, Urine Cassette), 150 replicates were used for each hCG concentration level (10 replicates per site x 3 sites x 5 days for each of 3 lots = 450 total data points per concentration level for each format). Total tests: 10 concentrations per serum format, 10 for urine strip, 10 for urine cassette. This would be a massive number, but the table combines the three lots and three operators. So for each concentration, 150 total tests (3 sites x 50 tests per site). This means for Serum Strip, 150 tests at 0 mIU/mL, 150 tests at 4 mIU/mL, and so on.
     • Provenance: This data was generated in vitro by spiking negative serum/urine specimens with hCG. The origin of the negative serum/urine is not specified (e.g., country) but is likely lab-obtained.
   • Test Set (Method Comparison): 120 urine samples and 120 serum samples were collected.
     • Provenance: The samples were collected prospectively from 120 women (ages 18-49, about half pregnant and in early stages

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Wunder Pregnancy Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in human urine. The device is visually read as an aid for the early detection of pregnancy and intended for in vitro single use. This test is intended for prescription use including at point-of-care sites.

Wunder Pregnancy Test is a single-use qualitative immunochromatic lateral flow device intended to detect human chorionic gonadotropin (hCG) in urine to help in the early detection of pregnancy. The device is visually read and intended for prescription use. Wunder Pregnancy Test is provided in a cassette format. A pipette is included for use with the device. The operator utilizes the included pipette to collect a sample of urine specimen to be tested from a sample cup. The operator then dispenses the urine specimen into the round sample well of the device. An absorbent, nitrocellulose membrane strip is incorporated in the sample well into the rectangular window where the results are read. In the results window, there are two band regions on the membrane strip, a test band and a control band. The test band region is pre-coated with Goat anti-a hCG antibodies. Goat anti-β monoclonal antibodies are placed on the membrane between the test band and the sample well. During the test, the urine sample is allowed to migrate upward and hydrate the anti-β monoclonal antibodies. The mixture then migrates along the membrane by capillary action to the immobilized Goat anti-α hCG antibodies in the test band region. In the presence of hCG in the urine, the anti-ß monoclonal antibodies bind with the hCG ß unit antigen and moves with the sample urine fluid by capillary action along the membrane. As the solution reaches the test band, the antibody hCG ß-unit antigen complex becomes linked to the pre-coated Goat anti-a hCG antibodies to form a visible precipitate that can be seen as a color line at the test band. Therefore, the formation of a visible color line on the test band region indicates the urine sample has tested positive for hCG. In the absence of hCG in the urine, the anti-ß monoclonal antibodies bypass the pre-coated Goat anti-q hCG antibodies in the test region without forming a visible precipitate. As a result, the absence of a visible color line in the test band region indicates the urine sample tested is negative for hCG. The distal control band region is pre-coated with Goat anti Mouse IgG. If there is sufficient urine volume, the anti-ß antibodies will migrate by capillary action to the control region. The anti-ß antibodies will bind with the Goat anti Mouse IgG and precipitate to form a color line. This antigen-antibody reaction at the control line ensures that the test is performed properly and should always be seen as a visible line duringtesting. The presence of this color band in the control region serves as verification that sufficient urine volume has been added and that proper flow was obtained. In conclusion, a valid positive urine sample produces two distinct color bands. A valid negative sample produces only one color band in the control zone.

Here's an analysis of the acceptance criteria and study details for the "Wunder Pregnancy Test" based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Method Comparison Study: 100 female patient urine samples. Data provenance is implied to be prospective and clinical, as samples were "collected and tested at three point of care locations." The country of origin is not explicitly stated.
• Sensitivity Study: 60 samples per hCG concentration level, for a total of 360 samples (60 samples x 6 concentrations: 0, 12.5, 20, 25, 37.5, 50, 100 mlU/mL - though the table only lists 7 concentrations, the summary states 60 samples per level). These were "urine samples from nonpregnant subjects were spiked with hCG," so this is a contrived, laboratory-based test set. Data provenance is not specified for country.
• Specificity, Interference (hCG beta-core fragment, Hook effect, Endogenous/Exogenous Substances): The sample sizes for these studies are not explicitly stated, but it implies multiple tests were conducted for each condition. These were also laboratory-based studies using spiked samples, not clinical patient samples for the interference parts.

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

• For Method Comparison: The ground truth for the 100 clinical samples was established by the predicate device (dBest Pregnancy Test). No human experts are explicitly mentioned as establishing a separate ground truth. The results of the Wunder Pregnancy Test were compared against the predicate device's results.
• For Sensitivity, Specificity, and Interference Studies: The ground truth was based on the known, spiked concentrations of hCG or other substances. No human experts were involved in establishing this ground truth, as it was chemically determined.

4. Adjudication Method for the Test Set

• For Method Comparison: No adjudication method is explicitly stated. The comparison was directly between the Wunder Pregnancy Test results and the predicate device's results. It's implied that the predicate device's result served as the "truth" for comparison.
• For other studies: Not applicable, as ground truth was based on known chemical concentrations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The studies focused on the performance of the device itself (standalone) or its agreement with a predicate device. There is no mention of human readers improving with or without AI assistance, as this is a visually read qualitative immunoassay, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies reported are essentially standalone performance studies for the device. The "Wunder Pregnancy Test" is a visually read device, meaning its "performance" is its intrinsic ability to produce a correct visual output based on the presence or absence of hCG. The performance results (sensitivity, specificity, agreement with predicate) are for the device itself. While a human reads the result, the performance metrics evaluate the device's ability to generate the correct visual signal.

7. The Type of Ground Truth Used

• Method Comparison: The ground truth was implicitly the result of the legally marketed predicate device (dBest Pregnancy Test) for the 100 clinical samples.
• Sensitivity, Specificity, Intervention Studies: The ground truth was based on known, controlled concentrations of hCG or other substances in laboratory-prepared (spiked) urine samples. This can be considered a form of analytical truth based on controlled experimental conditions.

8. The Sample Size for the Training Set

This information is not provided. The 510(k) summary describes performance testing for submission, not the development or training of the device. Given that this is a lateral flow immunoassay not an AI/ML device, a "training set" in the computational sense does not apply. The device's biological components (antibodies, etc.) are developed and manufactured, not "trained" on data.

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

As stated above, this is not applicable as the device is not an AI/ML model requiring a training set with established ground truth in that context. Its "training" would be the scientific and engineering development, optimization, and manufacturing processes of the immunoassay itself.

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The Fastep S10 hCG Serum/Urine Combo Test is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy. This product is only intended for prescription use in clinical laboratories and is not intended for point-of-care use settings.

Fastep S10 hCG Serum/Urine Combo Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine or serum for the early detection of pregnancy. During pregnancy, HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test devices are in two different formats: Strip, Cassette.

The Fastep S10 hCG Serum/Urine Combo Test is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens, intended as an aid in early detection of pregnancy. It is for prescription use in clinical laboratories and not for point-of-care use.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Precision/Reproducibility/Cut-Off Value Studies:
  • For serum (strip and cassette formats): 15 hCG concentrations were tested. For each concentration, 10 replicates were measured for 3 different lots, by 3 different operators, in 2 runs per day for 5 days. This sums to 10 replicates * 3 lots * 3 operators * 2 runs * 5 days = 900 tests per hCG concentration. The results tables show 30 results (10 replicates x 3 operators) per lot, and thus 90 results per hCG concentration across the 3 lots.
  • For urine (strip and cassette formats): Similar to serum, 15 hCG concentrations were tested. For each concentration, 10 replicates were measured for 3 different lots, by 3 different operators, in 2 runs per day for 5 days. This sums to 10 replicates * 3 lots * 3 operators * 2 runs * 5 days = 900 tests per hCG concentration. The results tables show 30 results (10 replicates x 3 operators) per lot, and thus 90 results per hCG concentration across the 3 lots.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be clinical laboratory settings given the intended use. These were spiked samples, not naturally occurring patient samples.
• High Dose Effect Study: Spiked negative urine/serum samples with 7 different high hCG concentrations. Tested by 3 different lots and 3 different operators. The number of replicates per concentration is not specified but the table shows a consistent positive result.
• Effects of hCG B-core fragment Study: Serum samples with 0mIU/mL and 10mIU/mL hCG were spiked with 14 different concentrations of B-core fragment. Urine samples with 0mIU/mL and 20mIU/mL hCG were spiked with the same B-core fragment concentrations. Tested by 3 different lots and 3 different operators. Number of replicates not specified.
• Effects of glycoprotein LH, FSH and TSH Study: Negative and positive samples (0 and 20 mIU/mL hCG for urine, 0 and 10 mIU/mL hCG for serum) were spiked with various concentrations of LH, FSH, and TSH. Tested by 3 different lots and 3 operators. Number of replicates not specified.
• Interference Study: Each of 19 interferents was spiked into hCG-free and hCG-positive (10mIU/mL for serum, 20mIU/mL for urine) samples. Each spiked sample was tested using 3 different lots of the kit. Number of replicates not specified but results for all 3 lots are shown.
• Effect of Urine Specific Gravity and pH Study: Urine samples (negative and positive at 20 mIU/mL hCG) tested at 6 pH values (4-9). Urine samples (negative and positive at 5 and 20 mIU/mL hCG) tested at 5 specific gravity values (1.000-1.035). Tested using 3 different lots by 3 different operators. Number of replicates not specified.
• Comparison Studies:
  • 100 urine samples and 100 serum samples were collected from 100 women.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The samples were "collected from 100 women (about half of them were pregnant, early stage at less than 5 weeks)." This suggests prospective collection for the study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Precision/Reproducibility/Cut-Off Value Studies: The "ground truth" (i.e., expected positive/negative based on hCG concentration) was established by using commercially available hCG traceable to the 4th WHO international Standard. These were spiked samples, so the hCG concentration was known.
• Comparison Studies: Ground truth for the 100 urine and 100 serum samples was established by the "results from predicate devices (QVUE)". It's not explicitly stated that experts established the ground truth for these samples; rather, the predicate device served as the reference.
• Other Studies (Specificity, Interference, pH/Specific Gravity): Ground truth was based on the known spiked concentrations of hCG or interferents.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Precision/Reproducibility/Cut-Off Value Studies, High Dose Effect, hCG B-core fragment, Glycoprotein hormones, Interference, pH/Specific Gravity: Data was collected by 3 different operators for each lot. The tables show the results from each individual lot, and then an "Overall Agreement" is calculated based on the total number of negative/positive results across the 3 lots. There is no explicit mention of an adjudication process (e.g., if operators disagreed).
• Comparison Studies: "Samples were tested by three different health professionals with the proposed and the predicate devices." It is not stated how discrepancies between the health professionals were resolved or if their readings were adjudicated. The summary tables combine results, implying an agreement or average.

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, this is not an MRMC comparative effectiveness study involving AI. It is a comparison study between a new device and a predicate device, using human readers for both. Therefore, no effect size of human readers improving with or without AI assistance is reported.

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

No, this device is a rapid visual immunoassay (test strip/cassette) intended to be interpreted visually by human users ("health professionals"). There is no algorithm or AI component, and thus no standalone algorithm-only performance was conducted or is applicable.

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

• For analytical performance metrics (precision, specificity, interference, pH/specific gravity), the ground truth was based on known spiked concentrations of hCG, interferents, or controlled pH/specific gravity levels. This is essentially a controlled laboratory standard.
• For the comparison studies, the ground truth was established by the predicate device (QuickVue One-Step hCG Combo test).

8. The sample size for the training set:

This device is not an AI/ML algorithm, so there is no "training set" in the conventional machine learning sense. The performance data presented are for verification and validation of the device's analytical and clinical performance.

9. How the ground truth for the training set was established:

As there is no AI/ML component, there is no "training set" or ground truth for a training set.

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The Sofia hCG FIA is an immunofluorescence-based lateral flow assay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine specimens and is designed to aid early detection of pregnancy. The test is intended for prescription use only, including use at point-of-care sites.

The test kit consists of individually packaged test Cassettes-each containing monoclonal murine antibodies for the capture and detection of hCG; disposable specimen transfer pipettes; and a package insert. The test is a qualitative immunofluorescence-based assay used to detect concentrations of 20 mIU/mL hCG or more in urine.

The Sofia hCG FIA is an immunofluorescence-based lateral flow assay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine specimens to aid early detection of pregnancy. The device is for prescription use only, including at point-of-care sites.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria for each performance metric as distinct pass/fail thresholds. However, the performance data presented can be interpreted as demonstrating the device meets the implied requirements for accuracy and reliability for its intended use.

• Positive Agreement: >99% (176/177) (95% Cl=97-100%)
• Negative Agreement: >99% (795/797) (95% Cl=99-100%)
• Overall Agreement: >99% (971/974) (95% Cl=99-100%) |

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

• Sample Size for Clinical Performance (Test Set): 974 fresh urine specimens.
• Data Provenance: The clinical study was multi-center, conducted by health care personnel at five (5) distinct sites in various geographical regions within the United States. The data is prospective, collected from patients presenting for pregnancy testing.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

The document does not specify the number or qualifications of experts used to establish the ground truth for the clinical test set. The clinical performance study compares the Sofia hCG FIA to "a commercially available qualitative test," implying that the result from this comparator test served as the reference or ground truth.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the clinical test set. The comparison is directly between the Sofia hCG FIA and a single "commercially available qualitative test."

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

A MRMC comparative effectiveness study was not explicitly performed or described in the provided text. The clinical study compares the device's performance to another commercial test, not to human readers with or without AI assistance. The Sofia hCG FIA is a rapid immunoassay read by an instrument (Sofia Analyzer), not an imaging device typically associated with MRMC studies involving human readers.

6. Standalone Performance:

Yes, standalone performance was assessed. The entire document describes the performance of the Sofia hCG FIA algorithm (via the Sofia Analyzer) in various analytical and clinical studies, independent of human interpretation or intervention in the diagnostic process beyond specimen collection and loading the cassette. The Sofia Analyzer dictates the development time, scans the strip, and analyzes the fluorescent signal using method-specific algorithms to display the result (Positive, Negative, or Invalid).

7. Type of Ground Truth Used:

• Analytical Performance Studies (Reproducibility, Detection Limit, High-Dose Hook Effect, Analytical Specificity): The ground truth was established using known, contrived samples prepared by spiking negative urine with specific, traceable concentrations of hCG (WHO International 4th Standard) or other substances.
• Clinical Performance Study: The ground truth was based on the results obtained from another commercially available qualitative test when evaluating clinical patient samples.

8. Sample Size for the Training Set:

The document does not explicitly state a separate "training set" for the Sofia hCG FIA. As a lateral flow immunoassay read by an analyzer with method-specific algorithms, the "training" would likely refer to the data used during the development and optimization of the instrument's algorithm and the assay reagents themselves. This information is not provided in detail, as the focus is on the validation performance of the finished product.

9. How Ground Truth for Training Set was Established:

As mentioned above, a "training set" is not explicitly described. However, during the development of such a device, a vast number of samples with known hCG concentrations (established through analytical methods, often traceable to international standards) would be used to develop and refine the detection algorithms and thresholds for the Sofia Analyzer. This would involve rigorous calibration and optimization to correctly identify positive and negative results across the intended range of hCG concentrations and ensure specificity. The performance studies detailed in the submission serve as the validation of this developed system.

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The Chemtrue® hCG urine or Combo test is a rapid lateral flow immunoassay for the visual qualitative detection of human chorionic gonadotropin (hCG) in human urine or serum as an aid in the early determination of pregnancy. The Dipstick/Cassette and Combo Tests are for prescription use only, including at physician's offices or other Point-Of-Care sites (POC).

The Chemtrue® hCG urine test is designed in Dipstick and Cassette formats. The hCG Combo (Serum/Urine) test is available in Cassette format only. Each test device consists of one (1) individual test strip and each test strip in the device consists of:

1. A conjugate pad contains colloidal gold conjugated with monoclonal anti-hCG antibody specific to the beta subunit of hCG.
2. A nitrocellulose membrane which is striped with the specific goat anti-hCG in the test line (T line) and goat anti-mouse antibody in the control line (C line serves as an internal quality control of the system and appears as a colored band during the test regardless of the hCG level in the test sample.
   All the configurations have the same membrane format, reagents and gold conjugate pad, as well as the same flow characteristics, except the test line in the nitrocellulose membrane for hCG Combo test is striped with polyclonal goat anti-hCG antibodies.
   Devices are packaged one device per foil pouch and 25 devices in each kit.

Here's a breakdown of the acceptance criteria and study information for the Chemtrue® Human Chorionic Gonadotropin (hCG) Pregnancy Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a bulleted list prior to presenting results, but rather demonstrates performance against the intended claims (e.g., cutoff levels, agreement with predicate). Based on the performance data, the implicit acceptance criteria are that the device demonstrates comparable sensitivity and specificity to the predicate devices, and consistent performance across lots, sites, and operators.

Chemtrue® hCG Pregnancy Urine Dipstick Test & Cassette Test (Cutoff: 20 mIU/mL)

Chemtrue® hCG Combo (Serum/Urine) Cassette Test (Cutoff: 25 mIU/mL)

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

• Sensitivity (Cutoff Characteristics) Study:

  • Sample Size: For each device format (Dipstick, Cassette, Combo Urine, Combo Serum), 3 lots were tested. For each lot, 6 hCG concentration levels (0, 10, 15, 20, 40, 80 mIU/mL for urine tests; 0, 10, 20, 25, 50, 100 mIU/mL for combo tests) were used with 5 replicates each.
    • Total for Urine tests: 3 lots * 6 concentrations * 5 replicates = 90 tests per urine format (Dipstick, Cassette)
    • Total for Combo tests: 3 lots * 6 concentrations * 5 replicates = 90 tests per Combo format (Urine, Serum)
  • Data Provenance: Spiked hCG urine/serum pools from non-pregnant donors. The origin of the donors/samples is not specified (e.g., country), but they are described as "human urine pool from non-pregnant donors" and "non-pregnant human serum and urine pools." This is a prospective spiking study.

• Reproducibility (Precision) Study:

  • Sample Size:
    • For each device format (Dipstick, Cassette, Combo Urine, Combo Serum), 3 lots were tested.
    • 7 hCG concentration levels for urine (0, 10, 15, 20, 25, 30, 35 mIU/mL) and 6 for serum (0, 15, 20, 25, 30, 35 mIU/mL).
    • Tested over 3 non-consecutive days with 3 operators per site across 3 sites. Each operator tested each control level (implied that 1 replicate for each level was run by each operator per day).
    • Calculation per device format and concentration level: 3 lots * 3 sites * 3 operators = 27 data points.
  • Data Provenance: Spiked hCG urine/serum controls, calibrated against WHO 5th IS, confirmed with Abbott i2000 instrument. The study was conducted at "three (3) POL sites." The geographical location of these POL sites is not explicitly stated. This is a prospective spiking study.

• Method Comparison Study:

  • Sample Size:
    • Urine: 300 clinical urine samples (150 hCG negative, 150 hCG positive).
    • Serum: 100 clinical serum samples (50 hCG negative, 50 hCG positive).
  • Data Provenance: Clinical samples from women who were suspected to be pregnant or non-pregnant women of childbearing age (including peri-menopausal). The study was conducted at "three (3) POL sites... in Shanghai China." The data is retrospective clinical samples (but prospective testing with the device).

• Analytical Specificity (Cross-reactivity) Study:

  • Sample Size: For each device format, 3 lots were tested. hLH, hFSH, hTSH, and other interfering substances were spiked into hCG negative and 50 mIU/mL controls (number of replicates not explicitly stated for all, but typically done in replicates).
  • hCGBcf interference: For each device format (Dipstick, Cassette, Combo Urine, Combo Serum), 3 lots were tested. 5 and 50 mIU/mL hCG controls were spiked with 4 hCGBcf concentrations. 10 replicates for each condition were tested (e.g., 3 lots * 2 hCG concentrations * 4 hCGBcf concentrations * 10 replicates = 240 tests for Dipstick, and similarly for other formats).
  • Data Provenance: Spiked samples.

• High Dose (Hook Effect) Study:

  • Sample Size: For each device format (Urine Tests: Dipstick, Cassette; Combo Tests: Urine, Serum), 3 lots were used. 5 hCG concentrations (50, 100, 200, 300, 500 IU/mL) were tested with 5 replicates per lot.
    • Total for Urine tests: 3 lots * 5 concentrations * 5 replicates = 75 tests per urine format.
    • Total for Combo tests: 3 lots * 5 concentrations * 5 replicates = 75 tests per combo format.
  • Data Provenance: Spiked non-pregnant urine and serum pools.

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

The ground truth for the test sets (except method comparison and analytical specificity, discussed below) was established by spiking known concentrations of hCG into negative samples, and these concentrations were "quantitatively confirmed by Abbott i2000 instrument." This means there were no human experts establishing ground truth for the spiked studies.

For the Method Comparison Study:

• The "hCG positive serum samples were quantitatively confirmed by Abbott i2000 instrument." This establishes a quantitative ground truth for positive samples.
• The "150 hCG negative urine samples (collected from women of childbearing age, including peri-menopausal)" and "50 hCG negative serum samples" implicitly had their negative status confirmed, likely through prior testing or knowledge that they were from non-pregnant individuals.
• For the comparison itself, the predicate devices (Genzyme Diagnostics OSOM® Card hCG Urine Test (K990578) and Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test (K964461)) served as the reference standard against which the new devices were compared. The predicate devices themselves would have been cleared based on their own performance against a ground truth. No specific "experts" are mentioned as establishing ground truth for this comparative study beyond the established performance of the predicate and quantitative instrumentation.

For Analytical Specificity (Cross-reactivity): The "ground truth" was the known presence of specific interfering substances and the known absence or presence of hCG at specific concentrations.

4. Adjudication Method for the Test Set

• Sensitivity, Reproducibility, High Dose, Analytical Specificity, and pH/SG studies: The results were interpreted at 5 minutes by the "same operator" who performed the test in the reproducibility study. In the sensitivity study, "three (3) operators" tested the samples. These studies used objective criteria (presence/absence of a line) and known hCG concentrations, so an explicit adjudication method beyond visual interpretation by the operator (or in some cases, multiple operators) is not described or typically required for this type of qualitative assay performance testing using spiked samples.
• Method Comparison Study: "Each specimen was evenly split into three aliquots. Each site tested 100 samples with a unique set of blind codes for each device formation." The test device's result was then compared to the predicate device's result. Discrepancies are noted (e.g., "One discrepant result in this table was from a single sample with a hCG concentration near the cut-off"). No explicit multi-reader adjudication method (like 2+1) is mentioned, as the comparison is against an established predicate device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a formal MRMC comparative effectiveness study was not explicitly done in the sense of comparing human readers with and without AI assistance. This document describes a traditional in-vitro diagnostic (IVD) device (a lateral-flow immunoassay) which is interpreted visually by a human. The studies performed are standard IVD performance characteristic studies.

The "Method Comparison Study" involved multiple operators (9 operators across 3 sites in Shanghai, China), but this was comparing the device's performance to a predicate device, not comparing human reader effectiveness with and without AI. It demonstrated that human readers could use the new device to achieve results comparable to predicate devices. Therefore, the concept of "effect size of how much 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

Yes, in essence, the fundamental performance characteristics (Sensitivity/Cutoff, Analytical Specificity, High Dose, pH/SG, Stability) of the device itself were tested in a standalone manner by evaluating its ability to correctly identify various concentrations of hCG or detect interfering substances, independent of human variability in clinical settings. These are tests of the device's inherent analytical performance.

However, since this is a visually-read qualitative immunoassay, the final "output" is inherently derived from human observation. The "Reproducibility (Precision) Study" assessed the consistency of this human observation across multiple users and sites, ensuring that the human-in-the-loop interpretation provided reliable results.

7. The Type of Ground Truth Used

• For Sensitivity/Cutoff, Reproducibility, Analytical Specificity, High Dose, pH/SG studies: The ground truth was known concentrations of hCG or other substances that were quantitatively confirmed by a reference instrument (Abbott i2000) or laboratory standards (WHO 5th IS 07/364). This is considered an analytical ground truth based on spiked samples.
• For Method Comparison Study: The ground truth for clinical samples was established by comparison against legally marketed predicate devices (Genzyme Diagnostics OSOM® Card hCG Urine Test and Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test). For serum samples, the hCG positive status was also quantitatively confirmed by an Abbott i2000 instrument. This is a comparative ground truth against an existing, cleared device, supported by quantitative confirmation for positives.

8. The Sample Size for the Training Set

The document describes the submission as a premarket notification (510(k)) for a new device. It does not explicitly mention a "training set" in the context of machine learning algorithms. This device is a lateral flow immunoassay, which does not typically involve training a computational algorithm. The studies described are performance validation studies for the finished device.

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

As there is no mention of a "training set" in the context of a machine learning algorithm, this question is not applicable. The device's fundamental design is based on immunological principles, not learned from a dataset.

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The Polymed Therapeutics' Fastep™ hCG Pregnancy Serum/Urine Test is a rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen to aid in the early detection of pregnancy. For Professional Use Only. The test kits are for health care professionals use including professionals at physician's office labs (POLs) and Point-of-Care site (POC).

The Fastep™ hCG Pregnancy Serum/Urine Test are distributed in Cassette format. Each test reagent strip contains mouse monoclonal anti-a-hCG antibody coated membrane and a dried chemical pad containing mouse monoclonal anti-B-hCG anybody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG.

Here's a breakdown of the acceptance criteria and study information for the Fastep™ hCG Pregnancy Serum/Urine Test, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state pre-defined acceptance criteria (e.g., "Sensitivity must be >= 95%"). Instead, it compares the device's performance to a predicate device (Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test) and declares "substantial equivalency." However, we can infer the performance metrics considered acceptable based on the reported results and the statement of substantial equivalency.

• Serum: 96.9% Positive, 3.1% Negative
• Urine: 96.9% Positive, 3.1% Negative
  (100% agreement for negative and higher positive concentrations) |
  | Interference | Performance not affected by specified pH, specific gravity, or presence of common substances (e.g., Acetaminophen, Albumin, Glucose). | Performance not affected by urine pH 3.0-8.5, specific gravity 1.00-1.03, or specified concentrations of 15 common substances. |

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

• Sample Size: 145 clinical specimen sets (referring to the combined urine and serum sets for accuracy correlation studies).
  • Urine: 145 samples (59 positive, 86 negative)
  • Serum: 145 samples (59 positive, 86 negative - derived from the 58 positive, 1 negative, 86 negative results)
• Data Provenance: Not explicitly stated as retrospective or prospective, nor is the country of origin specified beyond "clinical specimens." It's implied these are human clinical samples (urine and serum). The "POLs site study" suggests some data collected from Physician's Office Labs, which would be clinical settings.

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

• The 510(k) summary does not specify the number of experts or their qualifications for establishing the ground truth.

4. Adjudication Method for the Test Set

• The 510(k) summary does not explicitly state an adjudication method. For the accuracy studies, the clinical serum specimens were "quantitatively confirmed by Abbott Architect i2000 instrument." This implies the Abbott Architect i2000 results served as the reference standard for the clinical specimens.

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. This device is a rapid chromatographic immunoassay, which is a point-of-care test, not an AI-powered diagnostic imaging or interpretation device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

• Yes, effectively. This device is the standalone "algorithm" (biochemical reaction and visual interpretation) for detecting hCG. Its performance metrics (sensitivity, specificity, precision, cross-reactivity, interference) are all measures of its standalone capability to detect hCG in samples and provide a visual result. The "human-in-the-loop" aspect is the visual reading by a healthcare professional, but the performance data presented is for the device's ability to produce the correct positive/negative signal.

7. The Type of Ground Truth Used

• For the accuracy studies (clinical specimens): The ground truth for hCG concentration was established by quantitative confirmation using the Abbott Architect i2000 instrument (predicate device K093318). This is a well-established laboratory instrument for quantitative hCG measurement.
• For sensitivity, cross-reactivity, precision, and interference studies: The ground truth was established using known concentrations of hCG (e.g., 0 mIU/ml, 10 mIU/ml, 15 mIU/ml, 20 mIU/ml, 40 mIU/ml, 100 mIU/ml) and known concentrations of interfering substances, often in "spiked" samples. This represents a form of analytical gold standard or controlled experimental conditions.

8. The Sample Size for the Training Set

• This information is not provided in the 510(k) summary. For in vitro diagnostic (IVD) devices like this, the concept of a "training set" in the context of machine learning (where data is used to train an algorithm) is not directly applicable. The device's components (antibodies, reagents) are developed and optimized through R&D, and then validated with test sets.

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

• As mentioned above, the concept of a "training set" as commonly understood in AI/machine learning doesn't directly apply here. For the development and optimization of the test, the "ground truth" would have been established through well-characterized reference materials, known concentrations of hCG, and thorough analytical testing during the R&D phase to ensure the antibodies and test format functioned as intended. The 510(k) summary describes the validation testing, not the development process.

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