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The Applied DNA Technologies Bionexia™ hCG Pregnancy Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in urine to help in the early determination of pregnancy.

The test kits are for health care professionals use including professionals at physician's office labs (POLs).

For a final Diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

The Bionexia™ hCG Pregnancy Test will be distributed in both Cassette and Dipstick formats. Each test reagent strip contains mouse monoclonal anti-a-hCG antibody coated membrane and a dried chemical pad containing mouse monoclonal anti-ß-hCG anybody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG.

Here's a breakdown of the acceptance criteria and study details for the Bionexia™ hCG Pregnancy Cassette and Dipstick Tests, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided table shows (at 20 mIU/ml): 100% positive results across 4 lots (100 out of 100 specimens detected as positive at 20 mIU/ml).

For levels below 20 mIU/ml, there's a graded response, suggesting the 20 mIU/ml threshold is met (e.g., at 17.5 mIU/ml, 92% positive; at 15 mIU/ml, 56% positive). |
| Specificity (Cross-reactivity) | No cross-reaction with interfering substances at specified levels. | hCG (20 mIU/ml): 100% Non-cross-reactivity (This seems to imply 100% specific for hCG at 20mIU/ml, or perhaps the table header is misleading and it refers to 100% detection of hCG, but the context of "cross-reactivity" suggests it means no cross-reactivity with other substances at the hCG levels tested for specificity. Given the other rows, it's more likely this indicates it correctly identifies hCG and isn't cross-reacting with other substances as if it were hCG.).
hLH (300 mIU/ml): >500% (likely 0% cross-reactivity, implies at 300mIU/ml hLH, the device gives a negative result).
hFSH (1000 mIU/ml): >5.000% (likely 0% cross-reactivity).
hTSH (1.000 ulUmL): >5% (likely 0% cross-reactivity).
(Interpretation of "% Non-cross-reactivity" and the values 500% and 5.000% is ambiguous; it most likely means no detectable cross-reactivity at these high concentrations, where a negative result is desired.) |
| Reproducibility | Demonstrated consistency across multiple tests/lots. | Results demonstrated substantial equivalency with the predicate device. (Specific quantitative results not provided in the summary, but implied through this statement). |
| Safety and Effectiveness | Demonstrated as safe and effective. | Demonstrated as safe and effective in detecting hCG in urine. |

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

• Accuracy/Comparison Study (Test Set):
  • Sample Size: 95 clinical urine specimens (48 positive, 47 negative). An additional 49 specimens (20 negative, 29 positive) were re-evaluated at a third site.
  • Data Provenance: Clinical specimen correlation study, including POLs (Physician's Office Labs) site study. This indicates the data is prospective from clinical settings. The country of origin is not explicitly stated in the provided text, but the submitter's address is in San Diego, CA, USA, implying the study was likely conducted within the USA.
• Sensitivity/Cross-reactivity Study (Test Set):
  • Sample Size: For sensitivity, 100 specimens per level per lot, across 4 lots (totaling 400 specimens tested across the concentration curve). For cross-reactivity, the specific number of spiked samples is not given, but results are provided for various substances at specified levels.
  • Data Provenance: This appears to be a laboratory-based study using spiked controls, rather than clinical specimens for this specific component.

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

• The document does not explicitly state the number of experts or their specific qualifications for establishing ground truth.
• For the accuracy/comparison study, the comparison is made against a "predicate device" (ACON One Step Pregnancy Urine Test). The "ground truth" for these clinical samples is implicitly the result obtained from the predicate device, as the study aims to show agreement with it.
• For the sensitivity and cross-reactivity studies, the ground truth is established by the known concentration of spiked hCG or other substances.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method for the test set. Given that the comparison study is against a predicate device, it's likely that the predicate device's result was considered the reference, and discrepancies would have been examined, but the process is not detailed.

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, an MRMC comparative effectiveness study was not done. This device is a rapid diagnostic test (lateral flow immunoassay) for visual reading, not an AI-powered diagnostic imaging device that assists human readers.

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

• Yes, a standalone performance was done. This device is intended to be read visually by healthcare professionals, meaning its performance is inherently a "standalone" interpretation of the test result without an AI algorithm. The performance evaluation directly assesses the device's ability to produce accurate results.

7. The Type of Ground Truth Used

• Accuracy/Comparison Study: The ground truth for clinical specimens was derived from the results of the predicate device (ACON One Step Pregnancy Urine Test).
• Sensitivity and Specificity (Cross-reactivity) Studies: The ground truth was based on known concentrations of spiked analytes (hCG) and known concentrations of potential interfering substances. This is a form of laboratory-controlled ground truth.

8. The Sample Size for the Training Set

• The provided document does not mention a "training set" in the context of machine learning or AI. This is a point-of-care diagnostic device, not an AI/ML algorithm. Therefore, there is no training set in that sense. The studies described are performance validation studies.

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

• As there is no training set for an AI/ML algorithm, this question is not applicable to the Bionexia™ hCG Pregnancy Test.

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