(76 days)
The ACON™ Midstream Pregnancy Test is intended for home use, in the qualitative detection of human chorionic gonadotropin in urine.
ACON™ Midstream Pregnancy Test is intended for home use (over-the-counter) for the qualitative detection of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.
The ACON Midstream Pregnancy Test is a rapid chromatographic immunoassay (membrane particle assay).
Here's a breakdown of the acceptance criteria and the study information for the ACON™ Midstream Pregnancy Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from Predicate Device) | Reported Device Performance (ACON™ Midstream) | Meets Criteria? |
|---|---|---|---|
| Intended Use | qualitative detection of hCG in urine and serum, professional use | qualitative detection of hCG in urine and serum, home use (OTC) | Yes (differs in use setting, but still detects hCG qualitatively in urine and serum) |
| Indication for Use | early detection of pregnancy | early detection of pregnancy | Yes |
| Specimen | urine | urine | Yes |
| Endpoint | colored lines | colored lines | Yes |
| Format | test strips in device | test strips in device | Yes |
| Methodology | membrane particle assay | membrane particle assay | Yes |
| Storage | 15° to 30° C | 15° to 30° C | Yes |
| Test Time | 4 minutes | 3 minutes | Yes (improved/faster) |
| Sensitivity | 20 mIU/ml | 25 mIU/ml | No (less sensitive than predicate, but still within acceptable range for pregnancy tests) |
| Accuracy | ≥99% | ≤99% | Yes (stated as equivalent in the summary based on the difference in notation: '≤99%' implies at least 99%, while '≥99%' means equal to or greater than 99%. Given the overall claim of substantial equivalence, this would be interpreted as meeting or exceeding) |
| Specificity | No interferences | No interferences when tested with LH, FSH and TSH | Yes (more specific details provided) |
| Standardization | WHO Third International Standard | WHO Third International Standard | Yes |
Note on Sensitivity: While the ACON™ Midstream is listed as 25 mIU/ml and the predicate as 20 mIU/ml (meaning the predicate is more sensitive), the FDA's acceptance of substantial equivalence suggests that 25 mIU/ml is still considered clinically acceptable for home-use pregnancy detection. The document doesn't explicitly state the acceptance criteria for sensitivity, but rather compares it to the predicate.
2. Sample Size Used for the Test Set and the Data Provenance
The provided 510(k) summary does not contain information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be detailed in a separate study report or a more comprehensive section of the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The provided 510(k) summary does not contain information regarding the number or qualifications of experts used to establish ground truth. For a pregnancy test, ground truth would usually involve confirmed pregnancy status through other clinical methods (e.g., blood tests, ultrasound).
4. Adjudication Method for the Test Set
The provided 510(k) summary does not specify an adjudication method for the test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
A Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. This type of study is typically associated with imaging devices where multiple readers interpret cases with and without AI assistance. The ACON™ Midstream Pregnancy Test is an in-vitro diagnostic device that provides a direct result (colored lines) without requiring reader interpretation in the same way an imaging study would.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is an in-vitro diagnostic test kit that produces a visual result (colored lines). Its performance is inherently "standalone" in that it produces a result directly. There is no separate "algorithm" in the sense of a software program or AI that runs independently. The "human-in-the-loop" aspect here refers to the user interpreting the colored lines, which is part of its intended home use. The performance metrics (sensitivity, specificity, accuracy) would reflect the device's ability to correctly identify hCG levels.
7. The Type of Ground Truth Used
The type of ground truth used is not explicitly stated in the provided text. However, for a pregnancy test, ground truth would typically be established by comparing the test results to a gold standard method for confirming pregnancy, such as a quantitative blood hCG test (serum test) or, potentially, clinical outcomes data (e.g., documented pregnancy and subsequent birth). The mention of "WHO Third International Standard" implies calibration against a recognized standard for hCG.
8. The Sample Size for the Training Set
The provided 510(k) summary does not contain information regarding the sample size used for the training set. For an immunoassay device like this, the "training set" would likely refer to the samples and conditions used during the assay's development and optimization, rather than a machine learning training set.
9. How the Ground Truth for the Training Set was Established
The provided 510(k) summary does not contain information regarding how the ground truth for the training set was established. As with the test set, it would likely involve established methods for confirming hCG levels and pregnancy status during the device's development.
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.