FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

AimStick™ PBD Combo Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine or serum to aid in the determination of pregnancy. This test is for professional use.

Device Description

The test utilizes a combination of monoclonal antibodies to selectively detect elevated levels of hCG. The test strip is inserted into the specimen and the formation of colored bands is observed. 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 band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence or absence of hCG.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and study details:

Acceptance Criteria and Device Performance for AimStick™ PBD Combo Pregnancy

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided "Summary of Safety & Effectiveness," the primary acceptance criterion appears to be 100% concordance with a commercially available serum/urine pregnancy test.

Acceptance Criteria	Reported Device Performance (AimStick™ PBD Combo Pregnancy)
Primary: 100% concordance with a commercially available serum/urine pregnancy test for:

Positive Urine Results
Negative Urine Results
Positive Serum Results
Negative Serum Results | 100% concordance (AimStick™ Combo matches Commercially Available Combo kit in all categories) |
| Analytical Sensitivity: Detects hCG concentrations of 20 mIU/ml and greater. | Detects hCG concentrations of 20 mIU/ml and greater. |
| Specificity (Cross-Reactivity): No cross-reactivity with hLH (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 ulU/ml) in both negative (0 mIU/ml hCG) and positive (20 mIU/ml hCG) urine samples. | No cross-reactivity observed with hLH, hFSH, and hTSH at specified concentrations. |
| Procedural Control: A colored band should always appear at the Control Zone regardless of the presence or absence of hCG. | (Implied to be met, as it's described as a mandatory feature of the test's mechanism). |

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

Sample Size:
- Urine specimens: 155
- Serum specimens: 57
- Total Test Set Size: 212 specimens
Data Provenance:
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: Not explicitly stated, but the description "A multi-center clinical evaluation was conducted comparing the results obtained using AimStick™ PBD Combo Pregnancy and another commercially available serum / urine test" suggests a prospective collection and testing of samples for this comparative study.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. The study compares the AimStick™ Kit to "another commercially available serum / urine test" and finds 100% concordance. This implies that the "commercially available test" served as the reference standard, and no further adjudication (like 2+1 or 3+1 expert consensus) is described.

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

No, an MRMC comparative effectiveness study was not done. The study design described is a comparison of two diagnostic devices (AimStick™ Kit vs. a commercial predicate) on a set of specimens, not a study involving multiple human readers using an AI vs. without an AI.

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

Yes, a standalone performance evaluation was done. The AimStick™ PBD Combo Pregnancy device itself is an in-vitro diagnostic test. Its performance was directly compared against another commercial device, evaluating the detection of hCG by the device alone, without human interpretation variability being a primary focus of the performance data presented. The "reading" of the colored bands would be a human "in the loop" action, but the study focuses on the device's ability to produce the correct colored bands, not the variability of human readers interpreting those bands.

7. The Type of Ground Truth Used

The ground truth was established by a "commercially available serum / urine test." This is a form of predicate device comparison, where the established performance of an existing, legally marketed diagnostic device serves as the reference standard. The implicit assumption is that the predicate device's results are accurate.

8. The Sample Size for the Training Set

Not applicable / Not specified. This type of in-vitro diagnostic device (lateral flow immunoassay) typically does not involve a machine learning "training set" in the conventional sense. Its performance is based on the chemical and biological reactions of its components.

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

Not applicable / Not specified. As noted above, there isn't a "training set" for an algorithm in this context. The manufacturing specification and quality control for the immunological reagents and test strip components would be critical for establishing the inherent "truth" of the device's design.

Summary

Regulation Number and Section

§ 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.