(156 days)
Not Found
Not Found
No
The summary describes a standard immunoassay and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is used for diagnosis (detection of hCG to diagnose early pregnancy), not for treating or preventing a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "indicated as an aid for health care professionals in the diagnosis of early pregnancy."
No
The device description clearly states it is an "immunochromatographic assay," which is a physical test kit, 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 an immunoassay for the qualitative detection of human chorionic gonadotropin in human serum, plasma, or whole blood. This involves testing biological samples in vitro (outside the body).
- Diagnosis: The intended use also states it's indicated as an aid for health care professionals in the diagnosis of early pregnancy. IVDs are used to provide information for diagnostic purposes.
- Device Description: The description confirms it's an immunochromatographic assay, which is a common type of test performed in vitro on biological samples.
N/A
Intended Use / Indications for Use
An immunoassay used for the qualitative detection of human chorionic gonadotropin in human serum, plasma or whole blood and is indicated as an aid for health care professionals in the diagnosis of early pregnancy.
The ZAP™ hCG Test is an immunoassay used for the qualitative detection of human chorionic gonadotropin in human whole blood (capillary and heparinized venous), plasma or serum and is indicated as an aid for health care professionals in the diagnosis of early pregnancy.
Product codes
JHI
Device Description
The ZAP™ hCG Test is a one-step immunochromatographic assay for the rapid qualitative detection of hCG in human serum, plasma or whole blood.
Mentions image processing
Not Found
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 care 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
A total of 116 serum samples were tested and compared to the results obtained with the predicate device. The results of the two assays were in agreement except for four samples that were positive for hCG by the predicate device only. The discrepant samples were quantitated with the Beckman Access® Total β-hCG assay and the concentrations were in the range 2-6 mIU hCG/mL. Therefore, they were correctly reported as negative based on the 10 mIU hCG/mL cut-off value of the ZAP™ hCG Test.
Summary of Performance Studies
A number of evaluation studies were carried out on the ZAP™ hCG Test to determine the functional effectiveness of the test. Results of these studies included: (1) no interference from potentially interfering substances (albumin at 14 g/dL, bilirubin at 30 ng/dL, haemoglobin at 250 mg/dL, triglycerides at 2000 mg/dL); (2) no cross-reactivity to LH at 500 mIU/mL, FSH at 1000 mIU/mL, or TSH at 1000 µIU/mL; (3) >90% correlation of results from whole blood and plasma near the cut-off value; and (4) 100% agreement in a blind hCG study using spiked whole blood and involving three health care sites.
Key Metrics
Analytical Sensitivity: Whole blood, plasma, serum: 10 mIU/mL
Predicate Device(s)
ICON® II HCG ImmunoConcentration Assay marketed by Beckman Coulter, Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 1 8 2004
510(k) SUMMARY
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 501(k) number is: K033297 = .
Submitted by: ZBx Corporation 42 Laird Drive Toronto, Ontario M4G 3T2 Canada PHONE: 416-696-7208 FAX: 416-696-5593 Contact Person: Tracy Yang, Manager of Quality and Regulatory Affairs
| Date of Summary: | October 10, 2003 |
|---|---|
| Proprietary Name: | ZAP™ hCG Test |
| Common or | |
| Classification Name: | Human Chorionic Gonadotropin (hCG) Test System |
| Predicate Device: | ICON® II HCG ImmunoConcentration Assay marketed by |
| Beckman Coulter, Inc. | |
| Device Description: | The ZAP™ hCG Test is a one-step immunochromatographic |
| assay for the rapid qualitative detection of hCG in human serum, | |
| plasma or whole blood. | |
| Intended Use: | An immunoassay used for the qualitative detection of human |
| chorionic gonadotropin in human serum, plasma or whole blood | |
| and is indicated as an aid for health care professionals in the | |
| diagnosis of early pregnancy. |
1
| | ICON® II HCG Assay
(Predicate Device) | ZAP™ hCG Test |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Indications for Use | Determination of hCG in urine or serum
(The product insert discusses hCG as a marker for the early detection of pregnancy) | Qualitative detection of hCG in whole blood, plasma or serum to aid in the diagnosis of early pregnancy |
| Intended Users | Health care professionals | Health care professionals |
| Assay Format | Flow-through immunoassay | Chromatographic immunoassay |
| Detector Antibody | Monoclonal antibody to hCG is linked to alkaline phosphatase | Monoclonal antibody to hCG is linked to colloidal gold |
| Assay Indicators | Positive Control/Reference Zone
Negative Control Zone
Test Spot | Control Band
Test Band |
| Specimen | 450 µL of urine or serum | 35 µL of whole blood, plasma or serum |
| Test Procedure | Multi-step, multiple reagent addition test | One-step, no reagents required |
| Complexity | Sample is added to the test cylinder, enzyme-linked hCG 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 color reaction. | Sample is added to the test and allowed to react. |
| Analytical | Urine: 20 mIU/mL | Whole blood, plasma, serum: |
Comparison of Characteristics of the ZAP™ hCG Test with the Predicate Device:
:
2
| Agreement with
Predicate Device: | A total of 116 serum samples were tested and compared to the
results obtained with the predicate device. The results of the two
assays were in agreement except for four samples that were
positive for hCG by the predicate device only. The discrepant
samples were quantitated with the Beckman Access® Total β-
hCG assay and the concentrations were in the range 2-6 mIU
hCG/mL. Therefore, they were correctly reported as negative
based on the 10 mIU hCG/mL cut-off value of the ZAP™ hCG
Test. |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | A number of evaluation studies were carried out on the ZAP™
hCG Test to determine the functional effectiveness of the test.
Results of these studies included: (1) no interference from
potentially interfering substances (albumin at 14 g/dL, bilirubin at
30 ng/dL, haemoglobin at 250 mg/dL, triglycerides at 2000
mg/dL); (2) no cross-reactivity to LH at 500 mIU/mL, FSH at
1000 mIU/mL, or TSH at 1000 µIU/mL; (3) >90% correlation of
results from whole blood and plasma near the cut-off value; and
(4) 100% agreement in a blind hCG study using spiked whole
blood and involving three health care sites. |
| Conclusion: | The ZAP™ hCG Test performs as well as the ICON® II HCG
ImmunoConcentration Assay legally marketed by Beckman
Coulter Inc. |
:
:
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three horizontal lines above it, representing the department's mission to protect and promote the health of Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 8 2004
Ms. Tracy Yang Manager of Ouality and Regulatory Affairs ZBX Corporation 42 Laird Drive Toronto. CANADA M4G 3T2
Re: K033297
Trade/Device Name: ZAPTM hCG Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: February 17, 2004 Received: February 18, 2004
Dear Ms. Yang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):___K033297
Device_Name:_ZAP™ hCGi Test
Indications For Use:
The ZAP™ hCG Test is an immunoassay used for the qualitative detection of human The ZAF - TOO Test is an intimational (capillary and heparinized venous), chononic gonadotropin in haman i as an aid for health care professionals in the diagnosis of early pregnancy.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Division Sian
Office of In V Device Ev
510/k)
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