(32 days)
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.
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.
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.
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"Summary of Safety & Effectiveness"
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. The test utilizes a combination of monoclonal antibodies to selectively detect elevated levels of hCG. The a conformation of monoving the test strip into the specimen and observing for the formation of colored The specimen migrates via capillary action along the membrane to react with the colored bands. 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.
A multi-center clinical evaluation was conducted comparing the results obtained using AimStick™ PBD Combo Pregnancy and another commercially available serum / urine test. The study included 155 urine and 57 serum specimens tested with both assays. The following results were found:
| Positive UrineResults | Negative UrineResults | Positive SerumResults | Negative SerumResults | |
|---|---|---|---|---|
| AimStick™Combo | 79 | 76 | 19 | 38 |
| CommerciallyAvailable Combo kit | 79 | 76 | 19 | 38 |
AimStick™ PBD Combo Pregnancy showed a 100% concordance with the other commercially available serum / urine test.
AimStick™ PBD Combo Pregnancy detects hCG concentrations of 20 mIU/ml and greater. The test has been standardized to the World Health Organization al Standard. The addition of hLH (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 ulU/ml) to negative (0 mIU/ml hCC) and positive (20 mIU/ml hCG) urine showed no cross-reactivity.
Martin O'Connor, Regulatory Affairs
11-25-77
Date
Premarket Notification 510(k) Number
Page 1 of 16
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The text "HEALTH & HUMAN SERVICES • USA" is arranged in an arc above the caduceus. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN - 2 1998
Mr. Martin O'Connor General Manager Germaine Laboratories, Inc. 4203 Gardendale Center Suite 230 San Antonio, TX 78229
Re: K974512
Trade Name: AimStick™ PBD Combo Pregnancy Regulatory Class: II Product Code: DHA Dated: November 25, 1997 Received: December 1, 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 QS 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 Sutman
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: K974512
Device Name: AimStick™ PBD Combo Pregnancy
AimStick™ PBD Combo Pregnancy is intended for the qualitative "Indications For Use" -AlmStick FBD Comoo Trogiano Chorionic Gonadotropin) in urine or This test is for serum to aid in the determination of pregnancy. professional use.
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§ 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.