(43 days)
AimStick™ PBD Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy. This test is for professional use.
The test utilizes a combination of momelonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by dipping the test strip into urine and observing for the formation of colored bands. 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 of hCG.
Here's a breakdown of the acceptance criteria and the study details for the AimStick™ PBD Pregnancy test, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a numerical or percentage format beyond the concordance. However, based on the study's design and reported results, the implied acceptance criterion for substantial equivalence in this context is 100% concordance with a legally marketed predicate device.
| Acceptance Criteria | Reported Device Performance (AimStick™ PBD Pregnancy) |
|---|---|
| 100% concordance with a commercially available pregnancy test | 100% concordance with a commercially available test |
| Detection of hCG concentrations ≥ 20 mIU/ml | Detects hCG concentrations of 20 mIU/ml and greater |
| No cross-reactivity with hLH, hFSH, hTSH | No cross-reactivity reported |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 150 urine specimens.
- Data Provenance: Not specified (e.g., country of origin). The study is described as a "multi-center clinical evaluation," implying real-world samples. It is a retrospective study as it involves testing existing (collected) urine specimens.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number or qualifications of experts used to establish the ground truth for the test set. Instead of expert consensus, the "ground truth" for the comparative study was the result obtained from the "other commercially available test."
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. Since the "ground truth" was based on a single comparative test, an adjudication process as typically understood (e.g., 2+1 adjudication by human readers) was not applicable in this context. The concordance was directly calculated by comparing the results of the two tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted. This study compares the performance of a new device against a predicate device, rather than assessing improvements in human reader performance with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance evaluation was conducted. The AimStick™ PBD Pregnancy test is an in vitro diagnostic device, and its performance (detecting hCG, sensitivity, specificity/cross-reactivity) is assessed as a standalone product. The clinical evaluation compares its standalone performance to another standalone diagnostic. There is no "human-in-the-loop" component in the operation of this test strip.
7. The Type of Ground Truth Used
The primary ground truth for the "multi-center clinical evaluation" was the results obtained from a "commercially available test." This serves as a comparative ground truth for establishing substantial equivalence.
Additionally, internal validation was performed for the device's sensitivity and specificity:
- Sensitivity ground truth: Known concentrations of hCG (20 mIU/ml and greater) and negative urine (0 mIU/ml hCG) were used.
- Specificity/Cross-reactivity ground truth: Known concentrations of hLH, hFSH, and hTSH added to negative and positive urine were used.
8. The Sample Size for the Training Set
The document does not specify a training set sample size. For in vitro diagnostic devices like pregnancy tests, "training sets" in the context of machine learning (AI) are not typically applicable. The device's components (monoclonal and polyclonal antibodies) are developed and optimized through laboratory research and development, not by "training" an algorithm on a dataset.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" and associated ground truth is not applicable to this type of diagnostic device. The performance characteristics of the antibodies and test strip components are established through controlled laboratory experiments and analytical studies, not through AI training protocols.
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*974 368
JAN.2,1978
"Summary of Safety & Effectiveness"
AimStick™ PBD Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropia) in urine to aid in the determination of pregnancy. The test utilizes a combination of momelonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by dipping the test strip into urine and observing for the formation of colored bands. 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 of hCG.
A multi-center clinical evaluation was conducted comparing the results obtained using AimStick® PBD Pregnancy and another commercially available test. The study included 150 urine specimens tested with both assays. The following results were found:
| Positive Results | Negative Results | |
|---|---|---|
| AimStick™ | 78 | 72 |
| CommerciallyAvailable Test | 78 | 72 |
AimStick™ PBD Pregnancy showed a 100% concordance with the other commercially available test.
AimStick™ PBD Pregnancy detects hCG concentrations of 20 mIU/ml and greater. The test has been standardized to the World Health Organization Third International Standard. The addition of hI.H (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 ulU/ml) to negative (0 mIU/ml hCG) and positive (20 mIU/ml hCG) urine showed no cross-reactivity.
Martin O'Connor, Regulatory Affairs
11-18-97
Date
Premarket Notification 510(k) Number
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
$$\text{מאַטער}\text{ - מען באַרשע }$$
Mr. Martin O'Connor General Manager Germaine Laboratories, Inc. 4203 Gardendale Center Suite 230 San Antonio, TX 78229
K974368 Re: Trade Name: AimStick™ PBD Pregnancy Regulatory Class: II Product Code: DHA Dated: November 18, 1997 Received: November 20, 1997
Dear Mr. O'Connor:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
510(k) Number:_ K 974368
Device Name: AimStick™ PBD Pregnancy
"Indications For Use" -AimStick™ PBD Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy. This test is for professional use.
A+ AWM
(Division Sign-Off)
Division or Clinical Laboratory Devices
510(k) Number
(Please do not write below this point)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (per 21 CFR 801.109)
or
Over-The-Counter Use
2
§ 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.