(71 days)
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).
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.
The Instant-View™ LH Ovulation Predicting Test is a qualitative immunoassay designed to detect human Luteinizing Hormone (hLH) in human urine to predict ovulation. It is intended for professional and laboratory use only.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Device Performance (Reported) |
|---|---|
| Sensitivity | 20 mIU hLH/ml (WHO standards, LH 1st IRP 68/40) |
| Correlation with Predicate | 99% overall correlation with CLEARPLAN Easy™ One-Step Ovulation Predictor (K981271). Negative results agreed 97.4% (37/38). Positive results agreed 100% (62/62). |
| Reproducibility | 97.5% agreement across four evaluation sites (three Physician's Office Laboratories (POL) and one reference laboratory). Only one discrepancy observed, within the range of 25% below the cutoff. |
| Equivalence of Formats | No difference in performance between the cassette test and dip-strip test formats. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly mentions the following sample sizes for performance evaluation studies:
- Correlation Study:
- 38 negative results (compared to predicate)
- 62 positive results (compared to predicate)
The total number of samples isn't explicitly stated but can be inferred as at least 100 (38 negative + 62 positive) for the correlation study.
- Reproducibility Study: The number of samples for the reproducibility study is not explicitly stated, only that "all other results obtained were as expected" besides one discrepancy.
Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective as they involved evaluations by personnel in various laboratory settings.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: The reproducibility study states that "Evaluations were performed by personnel with diverse educational backgrounds and working experiences." This is a general statement and does not provide specific qualifications for establishing ground truth or interpreting results, beyond indicating they were laboratory personnel. For the correlation study, the ground truth seems to be established by comparison to the predicate device.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for establishing ground truth or resolving discrepancies. In the reproducibility study, one discrepancy was observed, but the resolution method is not detailed beyond stating it was "within the range of 25% below the cutoff."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is a diagnostic test kit, not a device requiring human-in-the-loop interpretation with an AI component. Therefore, the concept of "how much human readers improve with AI vs. without AI assistance" is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance evaluation was inherently done. The device itself is a one-step lateral flow chromatographic immunoassay that provides a visual result (presence of C line for control, T line for positive). The performance characteristics (sensitivity, correlation, reproducibility) are measured directly from the device's output, independent of an AI algorithm or complex human interpretation beyond reading the visible lines.
7. The Type of Ground Truth Used
- Correlation Study: The "ground truth" for the correlation study was established by comparison to a legally marketed predicate device (CLEARPLAN Easy™ One-Step Ovulation Predictor). The predicate device's results were assumed to be the correct reference.
- Sensitivity: The sensitivity of 20 mIU hLH/ml refers to a known concentration of hLH (WHO standards, LH 1st IRP 68/40). This indicates a laboratory-derived, quantitative standard.
8. The Sample Size for the Training Set
This information is not provided. As this is a traditional immunoassay device and not an AI/ML product, the concept of a "training set" in the context of machine learning is not applicable. The device's performance is based on its chemical and biological properties, not on a trained algorithm.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" is not relevant for this type of device. Therefore, no ground truth for a training set was established.
{0}------------------------------------------------
.
| 510(k) Summary ofSafety and Effectiveness as Required by 21 CFR 807.92 | |
|---|---|
| Submitter | Name: Alfa Scientific Designs, Inc.Address: 12330 Stowe DrivePoway, CA 92064Telephone: (858) 513-3888Fax: (858) 513-8388Contact Person: Naishu Wang, MD, Ph.D.E-mail: wnss@alfascientific.com |
| Device Name | Trade Name: Instant-View ™ LH Ovulation Predicting TestCommon Name: Luteinizing Hormone Test.Classification: Luteinizing Hormone Test System(21 CFR 862.1485)Class I |
| Date of SummaryPreparation | October 9, 2002 |
| Predicate Device | CLEARPLAN Easy™ One-Step Ovulation Predictor(K981271) |
| Device Description | This test is a one-step lateral flow chromatographicimmunoassay. |
| Summary of theSimilarity to thePredicate 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 aqualitative immunoassay for the detection of humanLuteinizing Hormone (hLH) in human urine to predict theoccurrence of ovulation. This device is intended forprofessional and laboratory use only. |
| PerformanceCharacters | The sensitivity of the device is 20mIU hLH/ml (WHOstandards, LH 1st IRP 68/40).The correlation between the Instant-View ™ OvulationPredicting Test and the legally marketed test compared is99%. The negative results agreed 97.4% (37/38). The positiveresults agreed 100% (62/62).The reproducibility of this device was studied at threePhysician's Office Laboratories (POL) and one referencelaboratory. Evaluations were performed by personnel withdiverse educational backgrounds and working experiences.Only one discrepancy was observed, that was within the rangeof 25% below the cutoff, and all other results obtained were asexpected. The results from the four evaluation sites agreed97.5%, indicating a high reproducibility of the device. |
| Two formats of thedevice, Dip-Stripand Cassette Test | Instant-View™ LH Ovulation Predicting Test has twoformats, cassette test and dip-strip test. The cassette testcontains the dip-strip in a plastic housing. Comparison studiesbetween the two formats demonstrated that there is nodifference in the performance of the cassette test and dip-striptest. |
| Conclusion | These results demonstrate that the Instant-View™ LHOvulation Predicting Test, in the format of cassette and dip-strip, is substantially equivalent to the legally marketed test. |
{1}------------------------------------------------
:
{2}------------------------------------------------
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.
{3}------------------------------------------------
Page 2 -
lage 2 -
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)
§ 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.