(30 days)
The ICON® Fx hCG test is a rapid qualitative test designed to detect human chorionic gonadotropin (hCG) in urine or serum, as an aid in the early detection of pregnancy. The ICON® Fx hCG test is for professional use.
The ICON® Fx hCG test uses two distinct monoclonal antibodies specific to the alpha and beta subunits of hCG to provide a test capable of detecting hCG concentrations as low as 20 mIU/mL urine and 10 mIU/mL serum (IU=International Units).
Here's an analysis of the acceptance criteria and study information for the ICON® Fx hCG Immunochemical Test based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, the study's goal appears to be demonstrating "substantial equivalence" to the predicate device, ICON® II HCG. The primary performance metric reported is "overall level of agreement" with the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (ICON® II HCG) | Overall level of agreement with ICON® II HCG was greater than 99.5% for both urine and serum samples. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of samples. The text mentions "multi-center clinical trial testing" (Section 4).
- Data Provenance: Not explicitly stated (e.g., country of origin). The text indicates it was from "multi-center clinical trial testing," suggesting prospective data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an in-vitro diagnostic test. "Ground truth" for such devices is established by comparing its results to a reference method or a legally marketed predicate device, as seen in the comparison to ICON® II HCG. There is no mention of human expert interpretation being the ground truth.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the ground truth is against a predicate device, not human expert interpretation that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study focused on the agreement between the new device (ICON® Fx hCG) and a predicate device (ICON® II HCG), not on comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone study was performed. The ICON® Fx hCG is a qualitative immunochemical test designed for visual detection without instrumentation required. Its performance (detection of hCG) is evaluated independent of a human-in-the-loop scenario beyond the visual interpretation of the test result itself. The agreement greater than 99.5% is the standalone performance of the Fx hCG compared to the predicate.
7. The Type of Ground Truth Used
The ground truth was established by comparison to a legally marketed predicate device, the ICON® II HCG ImmunoConcentration™ Assay.
8. The Sample Size for the Training Set
Not applicable. This is an immunoassay, not an AI/machine learning algorithm that requires a training set in the conventional sense. The "training" would be more akin to assay development and optimization, rather than machine learning training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the AI/machine learning context for this device. The development of the assay itself would involve optimizing its components to achieve desired sensitivity and specificity, likely against known hCG concentrations and reference materials.
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SKD, Inc. A Beckman Coulter Company
ICON® Fx hCG Immunochemical Test for hCG
510(k) Premarket Notification
KG81512
MAY 2 8 1998
510(k) SUMMARY ICON® Fx hCG Immunochemical Test for hCG
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _
| Developed by: | SKD, Inc. A Beckman Coulter Company1050 Page Mill Road, Bldg. 2BPalo Alto, CA USA 94303-0105Attention: Karen L. Richards, Manager, Clinicaland Regulatory AffairsPhone: (650) 845-3434, Fax (650) 845-3540 |
|---|---|
| Manufactured by: | Beckman Coulter San Diego8958 Terman CourtSan Diego, CA USA 92196-9006 |
| Proprietary name: | ICON® Fx hCG |
| Classification name: | Human Chorionic Gonadotropin Test System |
| Predicate Device: | ICON® II HCG ImmunoConcentrationTMAssay |
Karen L. Bishop
April 27, 1998
Date
Karen L. Richards Manager, Clinical and Regulatory Affairs
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| Device Description: | The ICON® Fx hCG test uses two distinctmonoclonal antibodies specific to the alpha andbeta subunits of hCG to provide a test capable ofdetecting hCG concentrations as low as 20mIU/mL urine and 10 mIU/mL serum(IU=International Units). |
|---|---|
| Intended Use: | A rapid qualitative test designed to detecthuman chorionic gonadotropin (hCG) in urine orserum, as an aid in the early detection ofpregnancy. |
| Labeling: | Labeling is provided in this 510(k) for multipleconfigurations of the ICON® Fₓ hCG test. Theurine-serum test differs from the urine test only bylabeling; all materials in the Test Card remain the |
same across the multiple configurations.
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Comparison of ICON® II HCG and ICON® Fx hCG Test Systems
| ICON® II HCG(Predicate Device) | ICON® Fx hCG | |
|---|---|---|
| Indicationsfor Use | An ImmunoConcentration™Assay for the Determinationof human chorionicgonadotropin (hCG) in urineor serum. (Summary andExplanation section of theproduct instructions discusseshCG as a marker for the earlydetection of pregnancy.) | A rapid, qualitative testdesigned to detect humanchorionic gonadotropin(hCG) in urine or serum, asan aid in the early detectionof pregnancy. |
| Used by | Health professionals | Health professionals |
| Principlesof the Test | ImmunoConcentration™Assay utilizing two specificmouse monoclonal antibodiesto the alpha and beta subunitsof the hCG molecule for thedetection of intact hCG. | ImmunochromatographicAssay utilizing the same twospecific mouse monoclonalantibodies to the alpha andbeta subunits of the hCGmolecule as the ICON® IIHCG test, for the detection ofintact hCG. |
| TestProcedure | Multi-step, multiple reagentaddition test. | One-step, no reagentsrequired. |
| Method ofDetection | Visual detection; noinstrumentation required. | Visual detection; noinstrumentation required. |
| ICON® II HCG(Predicate Device) | ICON® Fx hCG | |
| Chemical/BiologicalSafety | Universal biological safetyprecautions for samplehandling should be observed.Some reagents contain 0.1%sodium azide, and must bedisposed of using universalprecautions. | Universal biological safetyprecautions for samplehandling should be observed. |
| InternalControls | 1) Positive Control/ReferenceZone: With serum, theamount of color reactionpresent on the Test spot maybe compared to the colorreaction present on theControl/Reference spot, for asemi-quantitativeinterpretation at 25 mIUhCG/mL. For urine andserum, a positiveControl/Reference zonedemonstrates that the reagentswere working properly.2) Negative Control Zone:Identifies nonspecificimmunological binding orinsufficient washing. If colordevelops in the negativecontrol zone, the test isinvalid. | 1) Positive ProceduralControl: Demonstrates thatsample was added correctlyand the detection reagentswere working properly.2) Negative Control: Asecond line appearing in theTest Window, indicating thepresence of human anti-mouse antibodies in the testsample. Appearance of thissecond line indicates aninvalid test result.3) Flow Indicator: Bluecolor developing in the FlowIndicator window indicatesthat sample was addedproperly and flowed downthe test strip. |
| ICON® II HCG(Predicate Device) | ICON® Fx hCG | |
| Limit ofDetection | Urine: 20 mIU hCG/mLSerum: 10 mIU hCG/mL | Urine: 20 mIU hCG/mLSerum: 10 mIU hCG/mL |
| Specificity | No reaction with homologoushormones hLH, hFSH, hTSH— urine and serum | No reaction with homologoushormones hLH, hFSH, hTSH— urine; hLH, hFSH, hTSH,hPL and hGH - serum |
| Complexity | Sample is added to the testcylinder, enzyme-linkedantibody is added to thecylinder and allowed to react.Unbound antibody is washedaway, substrate solution isadded to the cylinder andallowed to react. Adding washsolution stops the reaction. | Sample is added to theSample Pad. The test card isclosed, and reactions takeplace. |
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Comparison of ICON® II HCG and ICON® Fx hCG Test Systems (continued)
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Comparison of ICON® II HCG and ICON® Fx hCG Test Systems (continued)
Additionally, the high level of agreement in the multi-center clinical trial testing supports the substantial equivalence of these two test kits. For both urine and serum samples, the overall level of agreement was greater than 99.5% (See Tab 8).
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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle's head and neck are formed by the silhouettes of the human profiles, creating a sense of unity and collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, emphasizing the organization's name and national affiliation.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 8 1998
Karen L. Richards · Manager, Clinical and Regulatory Affairs SKD, Inc. 1050 Page Mill Road, Bldg. 2B Palo Alto, California 94303-0105
Re : K981512 ICON® Fx hCG Immunochemical Test for hCG Regulatory Class: II Product Code: JHI Dated: April 27, 1998 Received: April 28, 1998
Dear Ms. Richards:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 General requlation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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.
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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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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 Statement
510(k) Number (if known):
Device Name: ICON® Fy hCG Immunochemical Test for hCG
Indications for Use: The ICON® Fx hCG test is a rapid qualitative test designed to detect human chorionic gonadotropin (hCG) in urine or serum, as an aid in the early detection of pregnancy. The ICON® Fx hCG test is for professional use.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 12981512
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
006
§ 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.