(156 days)
The ZAP™ hCG Test is 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 a one-step immunochromatographic assay for the rapid qualitative detection of hCG in human serum, plasma or whole blood.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ZAP™ hCG Test:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" with numerical thresholds against which the device was measured, as might be found in a highly structured clinical trial. Instead, it describes performance characteristics that were evaluated and compared to a predicate device. The primary success metric appears to be agreement with the predicate device and satisfactory performance in key analytical functional effectiveness studies.
| Performance Characteristic/Goal | Stated Performance (ZAP™ hCG Test) |
|---|---|
| Agreement with Predicate Device (ICON® II HCG ImmunoConcentration Assay) | "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." |
| Interference | "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)" |
| Cross-reactivity | "No cross-reactivity to LH at 500 mIU/mL, FSH at 1000 mIU/mL, or TSH at 1000 µIU/mL" |
| Correlation (Whole Blood and Plasma) | ">90% correlation of results from whole blood and plasma near the cut-off value" |
| Blind hCG Study (Spiked Whole Blood) | "100% agreement in a blind hCG study using spiked whole blood and involving three health care sites." |
| Conclusion of Equivalence | "The ZAP™ hCG Test performs as well as the ICON® II HCG ImmunoConcentration Assay legally marketed by Beckman Coulter Inc." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Agreement with Predicate Device: 116 serum samples.
- Blind hCG Study: Not explicitly stated, but involved "spiked whole blood."
- For other analytical studies (interference, cross-reactivity, whole blood/plasma correlation), specific sample sizes are not provided, but they are implied through the mention of "a number of evaluation studies."
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be retrospective in nature, particularly the comparison with the predicate device and the analytical evaluations using prepared samples (spiked whole blood, interfering substances). There is no mention of prospective clinical recruitment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the conventional sense. For this in vitro diagnostic device, the "ground truth" for the test set was established using:
- The results of a legally marketed predicate device (ICON® II HCG ImmunoConcentration Assay).
- A quantitative reference assay (Beckman Access® Total β-hCG assay) for discrepant samples.
- Laboratory measurements of known concentrations of interfering substances, cross-reactants, and spiked hCG levels.
There were no human experts establishing ground truth through interpretation for the performance studies described.
4. Adjudication Method for the Test Set
Not applicable for this type of in vitro diagnostic device study. Adjudication methods (like 2+1, 3+1) are typically used for studies where human interpretation of medical images or clinical cases forms the basis of ground truth, and discrepancies between readers need to be resolved. Here, the ground truth was based on instrument readings and reference assays.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance?
No, an MRMC comparative effectiveness study was not done. This device is an immunoassay for rapid qualitative detection of hCG, not an AI-assisted diagnostic tool that would be used by human readers in the interpretation of complex medical data. Therefore, the concept of human readers improving with AI assistance does not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies described are essentially standalone performance evaluations of the ZAP™ hCG Test as an algorithm/device only. The device is intended to provide a direct qualitative result (positive/negative) without requiring additional human interpretation of the result strip, beyond reading the control and test bands. The "blind hCG study using spiked whole blood and involving three health care sites" further supports this, as it evaluates the device's output accuracy in a practical setting without human interpretive variability being the primary focus.
7. The Type of Ground Truth Used
The ground truth used was a combination of:
- Predicate Device Results: The established performance of a legally marketed, substantially equivalent device (ICON® II HCG ImmunoConcentration Assay).
- Quantitative Reference Assay: The Beckman Access® Total β-hCG assay was used to resolve discrepancies with the predicate device, providing a quantitative "true" value for those samples.
- Known Concentrations: For interference and cross-reactivity studies, the ground truth was known concentrations of substances deliberately added or tested against.
- Spiked Samples: For the blind study, samples were "spiked" with known concentrations of hCG to establish a clear ground truth.
8. The Sample Size for the Training Set
Not applicable. The ZAP™ hCG Test is an immunoassay kit, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The device's performance is determined by its biochemical reagents and physical design, which are developed and validated through laboratory testing and manufacturing controls.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no "training set" for this type of device. The "ground truth" used during the development and validation of the assay (analogous to training/testing in ML) would involve careful preparation of samples with known hCG concentrations, interfering substances, and cross-reactants, followed by analytical testing to optimize the assay's sensitivity, specificity, and robustness.
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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 orClassification Name: | Human Chorionic Gonadotropin (hCG) Test System |
| Predicate Device: | ICON® II HCG ImmunoConcentration Assay marketed byBeckman Coulter, Inc. |
| Device Description: | The ZAP™ hCG Test is a one-step immunochromatographicassay for the rapid qualitative detection of hCG in human serum,plasma or whole blood. |
| Intended Use: | An immunoassay used for the qualitative detection of humanchorionic gonadotropin in human serum, plasma or whole bloodand is indicated as an aid for health care professionals in thediagnosis of early pregnancy. |
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| 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 ZoneNegative Control ZoneTest Spot | Control BandTest 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:
:
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| Agreement withPredicate Device: | A total of 116 serum samples were tested and compared to theresults obtained with the predicate device. The results of the twoassays were in agreement except for four samples that werepositive for hCG by the predicate device only. The discrepantsamples were quantitated with the Beckman Access® Total β-hCG assay and the concentrations were in the range 2-6 mIUhCG/mL. Therefore, they were correctly reported as negativebased on the 10 mIU hCG/mL cut-off value of the ZAP™ hCGTest. |
|---|---|
| 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 frompotentially interfering substances (albumin at 14 g/dL, bilirubin at30 ng/dL, haemoglobin at 250 mg/dL, triglycerides at 2000mg/dL); (2) no cross-reactivity to LH at 500 mIU/mL, FSH at1000 mIU/mL, or TSH at 1000 µIU/mL; (3) >90% correlation ofresults from whole blood and plasma near the cut-off value; and(4) 100% agreement in a blind hCG study using spiked wholeblood and involving three health care sites. |
| Conclusion: | The ZAP™ hCG Test performs as well as the ICON® II HCGImmunoConcentration Assay legally marketed by BeckmanCoulter Inc. |
:
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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
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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)
Page 1 of
§ 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.