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The Innovita Flu A/B Antigen Rapid Test is a rapid chromatographic immunoassay intended for the qualitative detection and differentiation of influenza A and B viral nucleoprotein antigens directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection.

The test is intended for use as an aid in the differential diagnosis of acute influenza A and B viral infections. The test is not intended to detect influenza C antigens. Negative test results are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions.

Performance characteristics for influenza A were established during the December 2023, and July 2024 influenza season when influenza A/H1N1pdm09, influenza A/H3N2 and influenza B/Victoria viruses were the predominant influenza viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If an infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The Innovita Flu A/B Antigen Rapid Test is a double antibody sandwich immunoassay-based test. The test device consists of the specimen zone and the test zone. The specimen zone contains monoclonal antibody against the Flu A/Flu B antigen labeled with latex microspheres and chicken IgY antibody conjugated with latex microspheres. The test line contains the other monoclonal antibody against Flu A/Flu B antigen. The control line contains rabbit anti-chicken IgY antibody.

After the specimen is applied into the specimen well of the device, antigen in the specimen forms an immune complex with the binding reagent in the specimen zone. Then the complex migrates to the test zone. The test line in the test zone contains antibody from a specific pathogen. If the concentration of the specific antigen in the specimen is higher than LoD of Flu A or Flu B, it will be captured at Flu A or Flu B line and form a red-purple line. In contrast, if the concentration of the specific antigen is lower than LoD, it will not form a red-purple line. The test also contains an internal control system. A red-purple control line (C) should always appear after the test is completed. Absence of a red-purple control line indicates an invalid result. The product contents are listed below.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance for Innovita Flu A/B Antigen Rapid Test

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria for the clinical study's Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA). However, the reported device performance is presented. For analytical performance (LoD, inclusivity, cross-reactivity, interfering substances), the acceptance criterion is generally 100% agreement or no interference/cross-reactivity as implied by the reported results.

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

• Test Set Sample Size (Clinical Study): 1101 evaluable nasopharyngeal swab specimens.
• Data Provenance:
  • Country of Origin: U.S.
  • Study Type: Prospective clinical study. Specimens were collected from subjects with flu-like symptoms during the 2023-2024 influenza season.

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

The ground truth for the clinical test set was established using an "FDA-cleared influenza A and B molecular assay" as the comparator method. The document does not specify the number of human experts involved in establishing this ground truth or their qualifications. The ground truth relies on the performance characteristics of the molecular assay itself.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the clinical test set results. The comparison appears to be a direct one-to-one comparison between the Innovita Flu A/B Antigen Rapid Test result and the result from the FDA-cleared molecular assay.

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

No MRMC comparative effectiveness study was done comparing human readers with AI vs. without AI assistance. This device is a rapid diagnostic test (RDT) with visual interpretation. The precision study involved "untrained operators" to assess reproducibility, but it was not a comparative effectiveness study with or without AI assistance.

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

Yes, this study primarily assesses the standalone performance of the rapid diagnostic test device. While human operators interpret the visual results, the performance metrics (PPA, NPA) are based on the device's output compared to the ground truth, without an explicit human-in-the-loop component being evaluated for its improvement with AI, as there is no AI component mentioned for interpretation.

7. Type of Ground Truth Used

The ground truth for the clinical study was: Comparator Method (FDA-cleared influenza A and B molecular assay).

8. Sample Size for the Training Set

The document does not explicitly state a sample size for a "training set." Rapid diagnostic tests typically do not involve machine learning algorithms that require a distinct training set in the same way an AI/ML device would. The development of the assay (e.g., antibody selection, optimization) is a different process from training a machine learning model.

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

Since a "training set" in the context of machine learning is not explicitly mentioned or applicable for this type of rapid diagnostic test, the method for establishing its ground truth is not applicable/not described. The analytical studies (LoD, inclusivity, specificity) use laboratory-prepared, characterized samples with known viral concentrations or presence/absence, serving as the "ground truth" for those specific analytical evaluations.

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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 INNOVITA HCG Pregnancy Rapid Test Strip detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only.

The INNOVITA HCG Pregnancy Rapid Test Cassette detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only.

The INNOVITA HCG Pregnancy Rapid Test Midstream detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only.

INNOVITA HCG Pregnancy Rapid Test will be sold in three different formats: cassette, test strip. and midstream. The test strip and midstream format contain a test device sealed in a desiccated aluminum pouch and a package insert. The cassette format contains one test device, a disposable plastic dropper and a package insert. INNOVITA HCG Pregnancy Rapid Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine for the detection of pregnancy. The test device contains mouse monoclonal anti-chCG antibody coated membrane and a pad containing mouse monoclonal anti-ß-hCG antibody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG.

Here's a breakdown of the acceptance criteria and study details for the INNOVITA HCG Pregnancy Rapid Test, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

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

   • Analytical Sensitivity: 30 replicates for each of 7 hCG concentrations ($0, 12.5, 18.75, 25, 37.5, 50, 100 \text{mIU/mL}$) per lot, across 3 lots and 3 device formats. This equates to $30 \times 7 \times 3 \times 3 = 1890$ individual tests. Data provenance is not explicitly stated but implies laboratory testing with spiked urine samples.
   • Cross-Reactivity: 5 devices from each format * (number of hormone concentrations) * (number of hCG presence levels). For example, for LH, it's $5 \times 3 \times 3 = 45$ tests for each format. Total tests for cross-reactivity with LH, FSH, and TSH: $45 \times 3 \times 3 + 45 \times 3 = 405 + 135 = 540$ (approximately) across all formats. Urine samples were spiked.
   • Endogenous/Exogenous Compounds: 5 devices from each format * (number of interferents) * (at least 2 levels). Urine samples were spiked. The exact total number of tests isn't calculated but would be substantial.
   • Urine pH: 5 devices from each format * (number of pH levels: 6) * (2 hCG levels: negative and $25 \text{mIU/mL}$). Total tests were $5 \times 6 \times 2 \times 3 = 180$ across all formats. Urine samples were adjusted for pH.
   • Urine Specific Gravity: 5 devices from each format * (number of SG ranges: 3) * (2 hCG levels: negative and $25 \text{mIU/mL}$). Total tests were $5 \times 3 \times 2 \times 3 = 90$ across all formats. Urine samples with different specific gravities were collected and spiked.
   • hCG β-core Fragment: 3 devices from each format * (number of fragment concentrations: 2) * (2 hCG levels: negative and $25 \text{mIU/mL}$). Total tests were $3 \times 2 \times 2 \times 3 = 36$ across all formats. Urine samples were spiked.
   • High Dose Hook Effect: 3 devices from each format * (number of hCG concentrations: 9). Total tests were $3 \times 9 \times 3 = 81$ across all formats. Urine samples were spiked.
   • Method Comparison with Predicate: 300 fresh urine samples from females aged 18-49. Prospective collection, but the country of origin is not specified.
   • Lay User Study: An unspecified number of females with diverse ethnic and educational backgrounds, aged 18-49. Prospective collection, but the country of origin is not specified.

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

   • For the Method Comparison Study, 5 Healthcare Professionals (HCPs) were involved in reading the tests. Their specific qualifications (e.g., years of experience, specialty) are not detailed.
   • For the Lay User Study, the "Healthcare Professional" performed the comparison test; their qualifications are not detailed beyond "Healthcare Professional."
   • For analytical studies (sensitivity, cross-reactivity, interference, etc.), ground truth was established by precise laboratory spiking of hCG or interferents, implying expert laboratory technicians were involved in preparing and verifying the concentrations.

3. Adjudication method for the test set:

   • For the Method Comparison Study and Lay User Study, the document mentions that a Healthcare Professional performed one test. It does not explicitly mention an adjudication method (like 2+1 or 3+1 for conflicting interpretations). For the lay user study, the comparison was between the lay user's result and the HCP's result, implying the HCP's result served as the reference for accuracy.
   • For analytical studies, results are based on observation of positive/negative lines based on known spiked concentrations, thus reducing the need for adjudication in the traditional sense.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study was done as this device is a manual, visual rapid test, not an AI-assisted diagnostic tool.

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

   • This is a standalone diagnostic device in the sense that its performance does not rely on a human reader's interpretation in the scientific validation, but rather on the objective appearance of a line. The "algorithm" is the biochemical reaction and visual detection. The performance data is the standalone performance of the device without human interpretation variability, aside from the lay user study where interpretation is tested as part of user-friendliness.

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

   • For analytical studies (sensitivity, cross-reactivity, interference, etc.), the ground truth was based on known, precisely spiked concentrations of hCG and other substances in urine samples. This is a highly controlled laboratory ground truth.
   • For the Method Comparison Study, the ground truth was established by the predicate device's result and the Healthcare Professional's concurrent reading of the new device.
   • For the Lay User Study, the ground truth for comparison was the Healthcare Professional's reading of the same urine sample using the same device format.

7. The sample size for the training set:

   • This document describes performance studies for a finished medical device (test strips), not a machine learning model. Therefore, there is no concept of a training set in the context of AI. The "training" of the device is its manufacturing process to ensure consistent biochemical reactivity.

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

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

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