INSTANT-VIEW LH OVULATION PREDICTING TEST

K022829 · Alfa Scientific Designs, Inc. · CEP · Nov 5, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022829
• Device Name: INSTANT-VIEW LH OVULATION PREDICTING TEST
• Applicant: Alfa Scientific Designs, Inc.
• Product Code: CEP · Clinical Chemistry
• Decision Date: Nov 5, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1485
• Device Class: Class 1

Intended Use

The Instant-View™ LH Ovulation Predicting Test is a qualitative immunoassay for the detection of human Luteinizing Hormone (hLH) in human urine to predict the occurrence of ovulation. This device is intended for professional and laboratory use only.

Device Story

Instant-View™ LH Ovulation Predicting Test is a lateral flow chromatographic immunoassay; detects hLH surge in human urine to predict ovulation. Device formats include dip-strip and cassette (dip-strip in plastic housing). Operation: visual inspection of test (T) and control (C) lines; presence of C line indicates valid test; presence of T line indicates positive result. Used in professional/laboratory settings (e.g., physician office labs) by healthcare personnel. Output is qualitative visual result; assists clinicians in identifying ovulation timing. Benefits patient by providing timely information for fertility management.

Clinical Evidence

Bench testing only. Sensitivity: 20mIU hLH/ml. Correlation with predicate: 99%. Negative percent agreement: 97.4% (37/38); positive percent agreement: 100% (62/62). Reproducibility evaluated at three Physician's Office Laboratories and one reference lab; 97.5% agreement across sites.

Technological Characteristics

Lateral flow chromatographic immunoassay; sandwich complex format. Two formats: dip-strip and cassette (plastic housing). Sensitivity: 20mIU hLH/ml (WHO 1st IRP 68/40). Visual interpretation of C and T lines.

Indications for Use

Indicated for healthcare professionals, including point-of-care settings like physician office labs, to detect human Luteinizing Hormone (hLH) in urine to predict ovulation.

Regulatory Classification

Identification

A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.

Predicate Devices

• CLEARPLAN Easy™ One-Step Ovulation Predictor (K981271)

Submission Summary (Full Text)

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K022829

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| 510(k) Summary of<br>Safety and Effectiveness as Required by 21 CFR 807.92 | |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Name: Alfa Scientific Designs, Inc.<br>Address: 12330 Stowe Drive<br>Poway, CA 92064<br>Telephone: [phone]<br>Fax: [phone]<br>Contact Person: Naishu Wang, MD, Ph.D.<br>E-mail: [e-mail] |
| Device Name | Trade Name: Instant-View ™ LH Ovulation Predicting Test<br>Common Name: Luteinizing Hormone Test.<br>Classification: Luteinizing Hormone Test System<br>(21 CFR 862.1485)<br>Class I |
| Date of Summary<br>Preparation | October 9, 2002 |
| Predicate Device | CLEARPLAN Easy™ One-Step Ovulation Predictor<br>(K981271) |
| Device Description | This test is a one-step lateral flow chromatographic<br>immunoassay. |
| Summary of the<br>Similarity to the<br>Predicate Device | The intended use and performance characteristics:<br>Both devices are intended to use for a detection of hLH surge in human urine. Technological characteristics:<br>Both devices are one step, qualitative, visual lateral flow immuno-Chromatographic test in a sandwich complex format. Interpretation of results:<br>The presence of C line serves as an internal quality control, and the presence of the T line indicates a positive result. |
| | |
| Intended Use | The Instant-View™ LH Ovulation Predicting Test is a<br>qualitative immunoassay for the detection of human<br>Luteinizing Hormone (hLH) in human urine to predict the<br>occurrence of ovulation. This device is intended for<br>professional and laboratory use only. |
| Performance<br>Characters | The sensitivity of the device is 20mIU hLH/ml (WHO<br>standards, LH 1st IRP 68/40).<br><br>The correlation between the Instant-View ™ Ovulation<br>Predicting Test and the legally marketed test compared is<br>99%. The negative results agreed 97.4% (37/38). The positive<br>results agreed 100% (62/62).<br><br>The reproducibility of this device was studied at three<br>Physician's Office Laboratories (POL) and one reference<br>laboratory. Evaluations were performed by personnel with<br>diverse educational backgrounds and working experiences.<br>Only one discrepancy was observed, that was within the range<br>of 25% below the cutoff, and all other results obtained were as<br>expected. The results from the four evaluation sites agreed<br>97.5%, indicating a high reproducibility of the device. |
| Two formats of the<br>device, Dip-Strip<br>and Cassette Test | Instant-View™ LH Ovulation Predicting Test has two<br>formats, cassette test and dip-strip test. The cassette test<br>contains the dip-strip in a plastic housing. Comparison studies<br>between the two formats demonstrated that there is no<br>difference in the performance of the cassette test and dip-strip<br>test. |
| Conclusion | These results demonstrate that the Instant-View™ LH<br>Ovulation Predicting Test, in the format of cassette and dip-<br>strip, is substantially equivalent to the legally marketed test. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with three lines forming the snake and staff.

## Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## NOV 5 2002

Naishu Wang, M.D., Ph.D. President Alfa Scientific Designs, Inc. 12330 Stowe Drive Poway, CA 92064

k022829 Re:

> Trade/Device Name: Instant-View™ LH Ovulation Predicting Test Regulation Number: 21 CFR 862.1485 Regulation Name: Luteinizing Hormone Test System Regulatory Class: Class I Product Code: CEP Dated: August 21, 2002 Received: August 26, 2002

Dear Dr. Wang:

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 (QS) 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 offer 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/dsmaldsmamain.html".

Sincerely yours.

Steven Butman

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) : K022829

DEVICE NAME : Instant-View™ LH Ovulation Predicting Test

INDICATIONS FOR USE:

The Instant-View™ LH Ovulation Predicting Test is a qualitative immunoassay for the detection of human Luteinizing Hormone (hLH) in human urine to predict the occurrence of ovulation. It is for health care professional use, including at the point of care (physician's office labs, doctor's offices).

Sare Cooper

(Division Sign-Off)

Division of Clinical Laboratory × 510(k) Number

(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 (Optional Format 1-2-96)