QUPID PLUS E.R.

K020378 · Stanbio Laboratory · JHI · Jun 21, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020378
• Device Name: QUPID PLUS E.R.
• Applicant: Stanbio Laboratory
• Product Code: JHI · Clinical Chemistry
• Decision Date: Jun 21, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

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.

Device Story

QuPID Plus E.R. is an in vitro diagnostic lateral flow immunoassay for qualitative hCG detection in serum or urine. Device utilizes membrane-based capillary action; specimen migrates along membrane to react with colored conjugate (polyclonal antibodies specific for hCG) and immobilized antibodies. Positive result indicated by colored line in specimen area; procedural control line appears in control area regardless of hCG presence. Used in clinical settings by healthcare personnel. Provides rapid visual qualitative results to aid pregnancy detection. Standardized to WHO Third International Standard.

Clinical Evidence

Clinical studies conducted at three locations with diverse operators. Accuracy evaluation compared QuPID Plus E.R. against a commercially available membrane test using 300 urine and 72 serum specimens. Results showed 100% concordance. Sensitivity established at 10 mIU/mL for serum and 20 mIU/mL for urine. Specificity testing confirmed no cross-reactivity with hLH (500 mIU/mL), hFSH (1000 mIU/mL), or hTSH (1000 µIU/mL).

Technological Characteristics

Lateral flow membrane immunoassay. Components: colored dye coated with polyclonal anti-hCG antibodies, immobilized anti-hCG antibodies, and monoclonal anti-mouse IgG antibodies. Sensitivity: 10 mIU/mL (serum), 20 mIU/mL (urine). Standardized to WHO Third International Standard. Non-automated, visual interpretation.

Indications for Use

Indicated for qualitative detection of hCG in serum or urine to aid in early pregnancy diagnosis. Intended for prescription use.

Regulatory Classification

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. 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.

Predicate Devices

• Abbott Test Pack® Plus

Submission Summary (Full Text)

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K020378

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<br>Results | Negative Urine<br>Results |
|--------------------------------|---------------------------|---------------------------|
| QuPID® Plus E.R. | 150 | 150 |
| Commercially<br>Available Test | 150 | 150 |
| | Positive Serum<br>Results | Negative Serum<br>Results |
| QuPID® Plus E.R. | 21 | 51 |
| Commercially<br>Available Test | 21 | 51 |

QuPID® Plus E.R. showed a 100% concordance with the other commercially available test for accuracy.

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# 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)