(30 days)
ICON® II HCG ImmunoConcentrationTM Assay
Not Found
No
The summary describes a rapid qualitative immunoassay test based on monoclonal antibodies, with no mention of AI or ML technologies.
No.
The device is a diagnostic test for pregnancy detection, not a device used to treat or alleviate a medical condition.
Yes
The device is used "as an aid in the early detection of pregnancy," which is a diagnostic purpose.
No
The device description clearly indicates it is a rapid qualitative test that uses monoclonal antibodies to detect hCG in urine or serum. This describes a physical test kit with biological components, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "rapid qualitative test designed to detect human chorionic gonadotropin (hCG) in urine or serum, as an aid in the early detection of pregnancy." This involves testing samples taken from the human body (urine or serum) in vitro (outside the body) to provide diagnostic information (detection of pregnancy).
- Device Description: The description details the use of antibodies to detect a specific substance (hCG) in biological samples (urine and serum). This is a hallmark of many IVD tests.
- Professional Use: The indication for "professional use" further supports its role in a healthcare setting for diagnostic purposes.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A rapid qualitative test designed to detect human chorionic gonadotropin (hCG) in urine or serum, as an aid in the early detection of pregnancy.
Product codes (comma separated list FDA assigned to the subject device)
JHI
Device Description
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).
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ICON® II HCG ImmunoConcentrationTM Assay
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Company
1050 Page Mill Road, Bldg. 2B
Palo Alto, CA USA 94303-0105
Attention: Karen L. Richards, Manager, Clinical
and Regulatory Affairs
Phone: (650) 845-3434, Fax (650) 845-3540 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufactured by: | Beckman Coulter San Diego
8958 Terman Court
San Diego, CA USA 92196-9006 |
| Proprietary name: | ICON® Fx hCG |
| Classification name: | Human Chorionic Gonadotropin Test System |
| Predicate Device: | ICON® II HCG ImmunoConcentrationTM
Assay |
Karen L. Bishop
April 27, 1998
Date
Karen L. Richards Manager, Clinical and Regulatory Affairs
1
| Device Description: | 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). |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | A rapid qualitative test designed to detect
human chorionic gonadotropin (hCG) in urine or
serum, as an aid in the early detection of
pregnancy. |
| Labeling: | Labeling is provided in this 510(k) for multiple
configurations of the ICON® Fₓ hCG test. The
urine-serum test differs from the urine test only by
labeling; all materials in the Test Card remain the |
same across the multiple configurations.
2
Comparison of ICON® II HCG and ICON® Fx hCG Test Systems
| | ICON® II HCG
(Predicate Device) | ICON® Fx hCG |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | An ImmunoConcentration™
Assay for the Determination
of human chorionic
gonadotropin (hCG) in urine
or serum. (Summary and
Explanation section of the
product instructions discusses
hCG as a marker for the early
detection of pregnancy.) | A rapid, qualitative test
designed to detect human
chorionic gonadotropin
(hCG) in urine or serum, as
an aid in the early detection
of pregnancy. |
| Used by | Health professionals | Health professionals |
| Principles
of the Test | ImmunoConcentration™
Assay utilizing two specific
mouse monoclonal antibodies
to the alpha and beta subunits
of the hCG molecule for the
detection of intact hCG. | Immunochromatographic
Assay utilizing the same two
specific mouse monoclonal
antibodies to the alpha and
beta subunits of the hCG
molecule as the ICON® II
HCG test, for the detection of
intact hCG. |
| Test
Procedure | Multi-step, multiple reagent
addition test. | One-step, no reagents
required. |
| Method of
Detection | Visual detection; no
instrumentation required. | Visual detection; no
instrumentation required. |
| | ICON® II HCG
(Predicate Device) | ICON® Fx hCG |
| Chemical/
Biological
Safety | Universal biological safety
precautions for sample
handling should be observed.
Some reagents contain 0.1%
sodium azide, and must be
disposed of using universal
precautions. | Universal biological safety
precautions for sample
handling should be observed. |
| Internal
Controls | 1) Positive Control/Reference
Zone: With serum, the
amount of color reaction
present on the Test spot may
be compared to the color
reaction present on the
Control/Reference spot, for a
semi-quantitative
interpretation at 25 mIU
hCG/mL. For urine and
serum, a positive
Control/Reference zone
demonstrates that the reagents
were working properly.
2) Negative Control Zone:
Identifies nonspecific
immunological binding or
insufficient washing. If color
develops in the negative
control zone, the test is
invalid. | 1) Positive Procedural
Control: Demonstrates that
sample was added correctly
and the detection reagents
were working properly.
2) Negative Control: A
second line appearing in the
Test Window, indicating the
presence of human anti-
mouse antibodies in the test
sample. Appearance of this
second line indicates an
invalid test result.
3) Flow Indicator: Blue
color developing in the Flow
Indicator window indicates
that sample was added
properly and flowed down
the test strip. |
| | ICON® II HCG
(Predicate Device) | ICON® Fx hCG |
| Limit of
Detection | Urine: 20 mIU hCG/mL
Serum: 10 mIU hCG/mL | Urine: 20 mIU hCG/mL
Serum: 10 mIU hCG/mL |
| Specificity | No reaction with homologous
hormones hLH, hFSH, hTSH
— urine and serum | No reaction with homologous
hormones hLH, hFSH, hTSH
— urine; hLH, hFSH, hTSH,
hPL and hGH - serum |
| Complexity | Sample is added to the test
cylinder, enzyme-linked
antibody is added to the
cylinder and allowed to react.
Unbound antibody is washed
away, substrate solution is
added to the cylinder and
allowed to react. Adding wash
solution stops the reaction. | Sample is added to the
Sample Pad. The test card is
closed, and reactions take
place. |
3
Comparison of ICON® II HCG and ICON® Fx hCG Test Systems (continued)
4
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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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 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
7
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