(136 days)
Abbott Test Pack® Plus
Not Found
No
The device description and performance studies describe a standard lateral flow immunoassay, which relies on chemical reactions and capillary action, not AI/ML. There is no mention of AI, ML, or image processing in the summary.
No.
The device is a diagnostic tool used to detect early pregnancy by identifying hCG, not to provide therapy for a medical condition.
Yes
The device is intended for the "qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy," which directly supports making a diagnosis of pregnancy.
No
The device description clearly outlines a physical test comprised of colored dye, antibodies, and a membrane, which are all hardware components. The assay involves adding a specimen to this physical device and observing for colored lines, indicating a chemical reaction and physical migration, not a software process.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy." This is a diagnostic test performed on biological specimens (serum or urine) outside of the body.
- Device Description: The description details how the test works by reacting with components in the specimen (hCG) to produce a result (colored lines). This is characteristic of an in vitro assay.
- Performance Studies: The performance studies describe testing with "urine and serum specimens," further confirming that the device is used to analyze biological samples.
The core function of the device is to analyze a biological sample (serum or urine) in a laboratory or similar setting to provide diagnostic information (presence of hCG for pregnancy detection). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
QuPID® Plus E.R. pregnancy device is intended for qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy.
Product codes
JHI
Device Description
The test is comprised of colored dye coated with polyclonal antibodies specific for hCG, immobilized antibodies against hCG and monoclonal anti-mouse lgG antibodies. The assay is conducted by adding specimen, urine or serum, 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 conjugate. 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.
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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy: An evaluation was conducted comparing the results obtained using QuPID® Plus E.R. and another commercially available urine/serum membrane test. The study included 300 urine and 72 serum specimens tested with both assays. QuPID® Plus E.R. showed a 100% concordance with the other commercially available test for accuracy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Specificity: The addition of hLH (500 mlU/ml), hFSH (1000 mlU/ml), and hTSH (1000 µlU/mL), to positive and negative urine/serum specimens showed no cross-reactivity.
Sensitivity: QuPID® Plus E.R. detects hCG concentration of 10 mlU/mL or greater in serum and 20 mIU/mL in urine.
Predicate Device(s)
Abbott Test Pack® Plus
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
JUN 2 1 2002
510(k) Summarv QuPID® Plus E.R.
QuPID® Plus E.R. pregnancy device is intended for qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. The test is comprised of colored dye coated with polyclonal antibodies specific for hCG, immobilized antibodies against hCG and monoclonal anti-mouse lgG antibodies. The assay is conducted by adding specimen, urine or serum, 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 conjugate. 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.
| Classification Name: | Gonadotropin |
|---|---|
| Classification Number: | 75DHA, Class II |
Predicate Device: Abbott Test Pack® Plus
PERFORMANCE CHARACTERISTICS
Accuracy:
An evaluation was conducted comparing the results obtained using QuPID® Plus E.R. and another commercially available urine/serum membrane test. The study included 300 urine and 72 serum specimens tested with both assays. The following results were found:
| | Positive Urine
Results | Negative Urine
Results |
|--------------------------------|---------------------------|---------------------------|
| QuPID® Plus E.R. | 150 | 150 |
| Commercially
Available Test | 150 | 150 |
| | Positive Serum
Results | Negative Serum
Results |
| QuPID® Plus E.R. | 21 | 51 |
| Commercially
Available Test | 21 | 51 |
QuPID® Plus E.R. showed a 100% concordance with the other commercially available test for accuracy.
1
510(k) Summary QuPID® Plus E.R. cont'd
Specificity:
The addition of hLH (500 mlU/ml), hFSH (1000 mlU/ml), and hTSH (1000 µlU/mL), to positive and negative urine/serum specimens showed no cross-reactivity.
Standardization:
The test has been standardized to the World Health Organization Third International Standard.
Sensitivity:
QuPID® Plus E.R. detects hCG concentration of 10 mlU/mL or greater in serum and 20 mIU/mL in urine.
CLINICAL STUDIES
Clinical Studies were conducted at three locations. The tests were conducted by individuals of diverse educational backgrounds and work experience. The results of these studies showed a 100% concordance with other commercially available tests.
CONCLUSION
The QuPID® Plus E.R. is substantially equivalent in principle and performance to Abbott's Test Pack® Plus as shown in this summary.
Summary prepared by Kirk Johnson, QA/QC Manager on January 30, 2002 Stanbio Laboratory 1261 North Main Street Boerne, Texas 78006
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the wings and a wavy line representing the staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 1 2002
Mr. Kirk Johnson QA/QC Manager Stanbio Laboratory 1261 North Main Street Boerne, TX 78006
Re: K020378
Trade/Device Name: QuPID Plus E.R. Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: April 25, 2002 Received: April 26, 2002
Dear Mr. Johnson:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Steven Sutman
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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| 510(k) Number (if known): | K020378 |
|---|---|
| Device Name: | QuPID Plus E.R. |
Indications For Use:
QuPID Plus E.R. is for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy.
Fran
Crop
(Division Sign-Off)
Division of Clinical Laborator evices
510(k) Number 020378
(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) $\checkmark$
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)