(25 days)
Acon™ Combo Pregnancy is intended for the rapid qualitative identification of hCG (human Chorionic Gonadotropin) in serum or urine to aid in the early determination of pregnancy. This test is for professional use.
The test utilizes a Combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by adding specimen to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line in the Specimen Area of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line in the Control Area will always appear regardless of the presence or absence of hCG.
Here's a breakdown of the acceptance criteria and study details for the Acon™ Combo Pregnancy device, based on the provided "Summary of Safety & Effectiveness":
Acceptance Criteria and Device Performance
The acceptance criteria for the Acon™ Combo Pregnancy device are implicitly defined by its claimed performance characteristics and its comparison to a "commercially available serum/urine membrane test." The study aims to demonstrate 100% concordance with this predicate device.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Qualitative Agreement | 100% concordance with a commercially available serum/urine membrane test for both positive and negative results in urine. | 100% concordance (71 positive, 88 negative for both Acon™ Combo and comparator) |
| Qualitative Agreement | 100% concordance with a commercially available serum/urine membrane test for both positive and negative results in serum. | 100% concordance (21 positive, 51 negative for both Acon™ Combo and comparator) |
| Inconclusive Results | Comparable rate of inconclusive results to the predicate device. | 1 inconclusive result for both Acon™ Combo and comparator in serum. (No inconclusive results reported for urine) |
| Sensitivity (Detection Limit) | Detects hCG concentrations of 25 mIU/ml and greater. | Device detects hCG concentrations of 25 mIU/ml and greater. |
| Standardization | Standardized to the World Health Organization Third International Standard. | Device has been standardized to the World Health Organization Third International Standard. |
| Cross-Reactivity | No cross-reactivity with hLH (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µIU/ml). | No cross-reactivity observed with the specified concentrations of hLH, hFSH, and hTSH in negative and positive serum and urine specimens. |
Study Information
-
Sample sizes used for the test set and the data provenance:
- Urine: 159 specimens
- Serum: 73 specimens
- Data Provenance: The document does not explicitly state the country of origin. It does not specify if the data was retrospective or prospective, but the phrasing "A multi-center clinical evaluation was conducted" suggests a prospective collection for this specific evaluation.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies that the "commercially available serum/urine membrane test" served as the reference standard for ground truth. It does not mention human experts establishing ground truth for the individual test samples. The "ground truth" is effectively derived from the results of the already-marketed comparative test.
-
Adjudication method for the test set:
- No adjudication method is described for discrepancies between the Acon™ Combo Pregnancy test and the comparator device, as 100% concordance was reported. If there were discrepancies, the document implies the comparator device's result would be the reference.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This study compares the performance of a diagnostic device against another diagnostic device, not human readers with and without AI assistance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The Acon™ Combo Pregnancy is a rapid qualitative identification test (a lateral flow immunoassay), not an algorithm or AI. Its performance, as described, is inherently standalone for detecting hCG. There is no human-in-the-loop component in its primary function of generating a result from a specimen.
-
The type of ground truth used:
- The ground truth relies on the results obtained from a "commercially available serum/urine membrane test." For the sensitivity and cross-reactivity studies, the ground truth would be based on known concentrations of hCG and other hormones.
-
The sample size for the training set:
- The document describes a clinical evaluation for validation/testing, but it does not mention a separate training set. This is typical for a traditional immunoassay device, which doesn't use machine learning algorithms that require explicit training datasets.
-
How the ground truth for the training set was established:
- As there's no mention of a training set for a machine learning algorithm, this question is not applicable. For the device itself, the "ground truth" for its development would have been established during its R&D phase using known concentrations of hCG and other substances, likely following validated laboratory methods and standards like the WHO Third International Standard.
§ 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.