(16 days)
AimStep™ 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 coningate. 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 an analysis of the provided text regarding the AimStep™ Combo Pregnancy device's acceptance criteria and studies:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the device demonstrating "100% concordance" with a "commercially available serum/urine membrane test." The performance is reported as follows:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| 100% concordance with a commercially available test for urine specimens | Urine Specimens: - AimStep™ Combo: 71 Positive, 88 Negative - Commercially Available Test: 71 Positive, 88 Negative - Concordance: 100% |
| 100% concordance with a commercially available test for serum specimens | Serum Specimens: - AimStep™ Combo: 21 Positive, 51 Negative, 1 Inconclusive - Commercially Available Test: 21 Positive, 51 Negative, 1 Inconclusive - Concordance: 100% |
| Detection of hCG concentrations of 20 mIU/ml and greater, standardized to the World Health Organization Third International Standard | The test "detects hCG concentrations of 20 mIU/ml and greater." "The test has been standardized to the World Health Organization Third International Standard." |
| No cross-reactivity with hLH, hFSH, and hTSH | "The addition of hLH (500 mIUml), hFSH (1000 mIU/ml), and hTSH (1000 ulU/ml) to negative and positive serum and urine specimens showed no cross-reactivity." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Urine specimens: 159
- Serum specimens: 73
- Total specimens: 232
- Data Provenance: The study was a "multi-center clinical evaluation." The country of origin is not explicitly stated, but the submission is to the US FDA, implying at least some relevance to the US. The study is retrospective, as it compared results obtained using the AimStep™ Combo Pregnancy and another commercially available test, suggesting these specimens were likely previously collected and tested, or tested concurrently as part of a comparative evaluation rather than a de novo prospective collection for the AimStep device alone.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their qualifications. The ground truth for the comparison was established by the "results obtained using another commercially available serum/urine membrane test." This implies that the 'ground truth' was essentially the result from the predicate device, not necessarily an independent expert panel review of clinical outcomes or pathology.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for disagreements. Since the study reported "100% concordance," it's possible there were no disagreements, or any disagreements were resolved in an unstated manner, or specimens leading to disagreement were simply excluded.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This was a comparison between two devices, not between human readers with and without AI assistance. The AimStep™ Combo Pregnancy is a qualitative rapid diagnostic test, not an AI-based diagnostic tool that assists human readers.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance study was done. The device itself, which functions as a qualitative rapid diagnostic test (an "algorithm" in a very broad sense, as it interprets color changes), was evaluated independently of human interpretation influence beyond reading the result. Its performance was measured by its ability to correctly identify hCG and its concordance with a predicate device.
7. Type of Ground Truth Used
The primary ground truth used for the comparative clinical evaluation was the results obtained from a "commercially available serum/urine membrane test." Additionally, the device's analytical performance (detection limit and cross-reactivity) was evaluated against established standards (WHO Third International Standard) and specific known concentrations of related hormones.
8. Sample Size for the Training Set
The document does not mention a training set or any training process for the AimStep™ Combo Pregnancy device. This type of diagnostic device, based on immunoassay, is typically developed through analytical chemistry and immunoassay design, rather than machine learning requiring a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, this question is not applicable to the provided information.
{0}------------------------------------------------
APR 1 6 1998
"Summary of Safety & Effectiveness"
AimStep™ 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. 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 coningate. 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.
A multi-center clinical evaluation was conducted comparing the results obtained using AimStep™ Combo Pregnancy and another commercially available serum/urine membrane test. The study included 159 urine and 73 serum specimens tested with both assays. The following results were found:
| PositiveUrine Results | NegativeUrine Results | ||
|---|---|---|---|
| AimStep™ Combo | 71 | 88 | |
| CommerciallyAvailable Test | 71 | 88 | |
| PositiveSerum Results | NegativeSerum Results | InconclusiveSerum Results | |
| AimStep™ Combo | 21 | 51 | 1 |
| CommerciallyAvailable Test | 21 | 51 | 1 |
AimStep™ Combo Pregnancy showed a 100% concordance with the other commercially available test.
AimStep™ Combo 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 hLH (500 mIUml), hFSH (1000 mIU/ml), and hTSH (1000 ulU/ml) to negative and positive serum and urine specimens showed no cross-reactivity.
Martin O'Connor Regulatory Affairs
3-30-98
Date
Martin O'Comer. Regulatory Affairs Germaine Laboratories. Inc. 4203 Gardendale Center, Suite 230 San Antonio, TX 78229 USA
Premarket Notification 510(k) Number
Page 1 of 18
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and well-being. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 16 1590
Martin O'Connor General Manager Germaine Laboratories, Inc. 4203 Gardenale Center, Suite 230 San Antonio, Texas 78229
Re : K981165 AimStep™ Combo Pregnancy Regulatory Class: II Product Code: JHI March 30, 1998 Dated: Received: March 31, 1998
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, Druq, 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 Requlations, Title 21, Parts 800 to 895. ದ 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 requlations.
{2}------------------------------------------------
Page 2
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 empirance at (301) 334-4633. preference 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
sincerely yours,
Steven Bitman
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
{3}------------------------------------------------
Indications For Use
510(k) Number:_
Device Name: AimStep™ Combo Pregnancy
And Antiques Company of the Comments of
AimStep™ Combo Pregnancy is intended for the rapid qualitative "Indications For Use" identification of hCG (human Chorionic Gonadotropin) in serum or urine to aid in the early determination of pregnancy. This test is for professional use.
(Please do not write below this point)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| for H. Montgomery | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | A981165 |
| Prescription Use | or | Over-The-Counter Use | |
|---|---|---|---|
| (per 21 CFR 801.109) |
Page 3 of 18
§ 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.