(71 days)
No
The description details a lateral flow immunoassay, which is a chemical test, and there is no mention of AI/ML terms, image processing, or data training/testing.
No
The device is an in vitro diagnostic (IVD) test used to predict ovulation by detecting Luteinizing Hormone. It is not designed to treat or prevent a medical condition.
Yes
The "Intended Use / Indications for Use" states that the device is a "qualitative immunoassay for the detection of human Luteinizing Hormone (hLH) in human urine to predict the occurrence of ovulation," which is a diagnostic purpose.
No
The device description clearly states it is a "one-step lateral flow chromatographic immunoassay" with "two formats, cassette test and dip-strip test," indicating it is a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "detection of human Luteinizing Hormone (hLH) in human urine to predict the occurrence of ovulation." This involves testing a biological sample (urine) in vitro (outside the body) to gain diagnostic information (predicting ovulation).
- Device Description: It's described as a "qualitative immunoassay," which is a common type of test used in IVD devices to detect specific substances in biological samples.
- Intended User / Care Setting: While it's for professional and laboratory use, and healthcare professionals at the point of care, this doesn't preclude it from being an IVD. Many IVDs are used in these settings.
- Performance Studies: The description includes performance metrics like sensitivity, correlation, and reproducibility, which are typical evaluations for IVD devices to demonstrate their accuracy and reliability.
- Predicate Device: The mention of a predicate device (K981271; CLEARPLAN Easy™ One-Step Ovulation Predictor) is a strong indicator that this device is being compared to another legally marketed IVD.
The core function of analyzing a human biological sample (urine) in vitro to provide diagnostic information (predicting ovulation) aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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. This device is intended for professional and laboratory use only.
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).
Product codes
CEP
Device Description
This test is a one-step lateral flow chromatographic immunoassay.
Instant-View™ LH Ovulation Predicting Test has two formats, cassette test and dip-strip test. The cassette test contains the dip-strip in a plastic housing. Comparison studies between the two formats demonstrated that there is no difference in the performance of the cassette test and dip-strip test.
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
professional and laboratory use only.
health care professional use, including at the point of care (physician's office labs, doctor's offices).
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)
The sensitivity of the device is 20mIU hLH/ml (WHO standards, LH 1st IRP 68/40).
The correlation between the Instant-View ™ Ovulation Predicting Test and the legally marketed test compared is 99%. The negative results agreed 97.4% (37/38). The positive results agreed 100% (62/62).
The reproducibility of this device was studied at three Physician's Office Laboratories (POL) and one reference laboratory. Evaluations were performed by personnel with diverse educational backgrounds and working experiences. Only one discrepancy was observed, that was within the range of 25% below the cutoff, and all other results obtained were as expected. The results from the four evaluation sites agreed 97.5%, indicating a high reproducibility of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 20mIU hLH/ml (WHO standards, LH 1st IRP 68/40).
Correlation: 99%
Negative results agreement: 97.4% (37/38)
Positive results agreement: 100% (62/62)
Reproducibility agreement: 97.5%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1485 Luteinizing hormone test system.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
.
| 510(k) Summary of
| Safety and Effectiveness as Required by 21 CFR 807.92 | |
|---|---|
| Submitter | Name: Alfa Scientific Designs, Inc. |
| Address: 12330 Stowe Drive | |
| Poway, CA 92064 | |
| Telephone: (858) 513-3888 | |
| Fax: (858) 513-8388 | |
| Contact Person: Naishu Wang, MD, Ph.D. | |
| E-mail: wnss@alfascientific.com | |
| Device Name | Trade Name: Instant-View ™ LH Ovulation Predicting Test |
| Common Name: Luteinizing Hormone Test. | |
| Classification: Luteinizing Hormone Test System | |
| (21 CFR 862.1485) | |
| Class I | |
| Date of Summary | |
| Preparation | October 9, 2002 |
| Predicate Device | CLEARPLAN Easy™ One-Step Ovulation Predictor |
| (K981271) | |
| Device Description | This test is a one-step lateral flow chromatographic |
| immunoassay. | |
| Summary of the | |
| Similarity to the | |
| Predicate Device | The intended use and performance characteristics: |
| Both devices are intended to use for a detection of hLH surge in human urine. Technological characteristics: | |
| Both devices are one step, qualitative, visual lateral flow immuno-Chromatographic test in a sandwich complex format. Interpretation of results: | |
| 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 |
| 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. | |
| Performance | |
| Characters | The sensitivity of the device is 20mIU hLH/ml (WHO |
| standards, LH 1st IRP 68/40). |
The correlation between the Instant-View ™ Ovulation
Predicting Test and the legally marketed test compared is
99%. The negative results agreed 97.4% (37/38). The positive
results agreed 100% (62/62).
The reproducibility of this device was studied at three
Physician's Office Laboratories (POL) and one reference
laboratory. Evaluations were performed by personnel with
diverse educational backgrounds and working experiences.
Only one discrepancy was observed, that was within the range
of 25% below the cutoff, and all other results obtained were as
expected. The results from the four evaluation sites agreed
97.5%, indicating a high reproducibility of the device. |
| Two formats of the
device, Dip-Strip
and Cassette Test | Instant-View™ LH Ovulation Predicting Test has two
formats, cassette test and dip-strip test. The cassette test
contains the dip-strip in a plastic housing. Comparison studies
between the two formats demonstrated that there is no
difference in the performance of the cassette test and dip-strip
test. |
| Conclusion | These results demonstrate that the Instant-View™ LH
Ovulation Predicting Test, in the format of cassette and dip-
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 (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/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
4
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)