(27 days)
Not Found
No
The device description and performance studies focus on a traditional immunoassay for detecting hCG. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device is intended for detection, which is a diagnostic purpose, not for therapy or treatment.
Yes
The device is described as an "aid in early detection of pregnancy" and measures the presence of hCG in urine, which are characteristics of a diagnostic test performed to identify a condition or disease.
No
The device description clearly states it is a physical test device (Strip, Cassette, Midstream) that detects hCG in urine, and includes physical components like a test device sealed in a pouch and a dropper. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy." This describes a test performed on a sample taken from the human body (urine) to provide information about a physiological state (pregnancy).
- Device Description: The description details a test that "measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine." This further confirms it's analyzing a biological sample.
- Performance Studies: The performance studies involve testing urine samples from individuals to evaluate the device's ability to detect hCG and determine pregnancy status. This is characteristic of IVD testing.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The WHOLEPOWER Pregnancy Rapid Test fits this definition perfectly.
N/A
Intended Use / Indications for Use
WHOLEPOWER Pregnancy Rapid Test Cassette is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.
WHOLEPOWER Pregnancy Rapid Test Midstream is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.
WHOLEPOWER Pregnancy Rapid Test Strip is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
WHOLEPOWER Pregnancy Rapid Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine for the early detection of pregnancy. The test devices are in three different formats: Strip, Cassette and Midstream. Each test kit contains a test device sealed in a desiccated aluminum pouch and a package insert. The cassette format also contains a dropper.
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
Over the counter use
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
A. Analytical performance
Negative urine was spiked with hCG standard (Traceable to the 4th WHO) to hCG concentrations of 0, 12.5, 18.75, 22.5, 25, 50, 100 and 200mIU/mL. The spiked samples were measured in replicates using 3 different lots for each format. Tests were performed by three different operators for each sample concentration in 2 runs per day for 15 days.
B. Method comparison study
Urine samples were collected from 120 women presenting to test for pregnancy at OB/GYN Physician's offices. Approximately half of the 120 women were suspected to be pregnant and most of them are in the early stage of less than 5 weeks. All samples were tested by two different health professionals for each format at each of the 3 OB/GYN Physician's offices for a total of 18 operators with the proposed and the predicate devices.
C. Lay person study:
300 women's individual pregnancy status was self-tested, varying educational and occupational backgrounds from three sites were chosen for the study. Each subject tested her own urine sample using the candidate device according to the package insert. Each subject also provided a sample for professional testing with the candidate device as well.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. Analytical performance: Tests were performed to evaluate precision/reproducibility/sensitivity, linearity/assay reportable range, hook effect, traceability, stability, expected values, specificity and cross-reactivity, and interfering substances. The sensitivity of WHOLEPOWER® Pregnancy Rapid Test is demonstrated to be 25 mIU/mL. No hook effect was observed at hCG concentrations ranging from 62500 to 2000000 mIU/mL. No interferences were observed from listed exogenous compounds, changes in pH (4-9), or changes in specific gravity.
B. Method comparison study: The performance of the new device was compared to the predicate test (WHPM One Step Pregnancy Test K041273). Urine samples were collected from 120 women. The results indicate an over 98% agreement between the proposed and the predicate for Strip, Cassette, and Midstream formats.
C. Lay person study: 300 women self-tested their urine samples. The lay person results showed 100% positive and >97% negative conformity with the professional results. A questionnaire indicated that consumers found the test easy to use and understood the labeling and interpretation of results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 25 mIU/mL
Agreement with predicate: > 98%
Lay person positive conformity: 100%
Lay person negative conformity: > 97%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
WHPM One Step Pregnancy Test (K041273)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 15, 2019
Wholepower Biotech Co., Ltd. % Joe Shia, Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877
Re: K190705
Trade/Device Name: WHOLEPOWER Pregnancy Rapid Test Cassette WHOLEPOWER Pregnancy Rapid Test Strip WHOLEPOWER Pregnancy Rapid Test Midstream Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (hCG) test system Regulatory Class: Class II Product Code: LCX Dated: March 15, 2019 Received: March 19, 2019
Dear Joe Shia:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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K190705
510(k) SUMMARY
| 1. | Date: | April 12, 2019 |
|---|---|---|
| 2. | Submitter: | Wholepower Biotech Co., Ltd. |
| Dongfengdong Road, Guangzhou, | ||
| China 510008 | ||
| 3. | Contact person: | Joe Shia |
| LSI International Inc. | ||
| 504 East Diamond Ave., Suite J | ||
| Gaithersburg, MD 20877 | ||
| Telephone: 240-505-7880 | ||
| Fax: 301-916-6213 | ||
| Email:shiajl@yahoo.com | ||
| 4. | Device Name: | WHOLEPOWER® Pregnancy Rapid Test Cassette |
| WHOLEPOWER® Pregnancy Rapid Test Midstream | ||
| WHOLEPOWER® Pregnancy Rapid Test Strip | ||
| Classification: | Class II | |
| Product Code | LCX | |
| CFR | 862.1155 | |
| 5. | Predicate Devices: | WHPM One Step Pregnancy Test (K041273) |
6. Intended Use
WHOLEPOWER Pregnancy Rapid Test Cassette is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.
WHOLEPOWER Pregnancy Rapid Test Midstream is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.
WHOLEPOWER Pregnancy Rapid Test Strip is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.
7. Device Description
WHOLEPOWER Pregnancy Rapid Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine for the early detection of pregnancy. The test devices are in three different formats: Strip, Cassette and
4
Midstream. Each test kit contains a test device sealed in a desiccated aluminum pouch and a package insert. The cassette format also contains a dropper.
| Similarities | ||
|---|---|---|
| Item | Candidate device | Predicate device |
| K041273, WHPM One | ||
| Step Pregnancy Test | ||
| Intended use | Early detection of | |
| pregnancy | Early detection of | |
| pregnancy | ||
| Specimen | Urine | Urine |
| Assay technical | Immunochromatographic | |
| assay | Immunochromatographic | |
| assay | ||
| Sensitivity | 25 mIU/mL | 25 mIU/mL |
| Results | Qualitative | Qualitative |
| Target user | Over the counter use | Over the counter use |
| Device format | Strip, Cassette, Midstream | Strip, Cassette, Midstream |
| Differences | ||
| Item | Device | Predicate |
| Reading Time | 3 minute | 5 minute |
Substantial Equivalence Information 8.
9. Test Principle
The test uses colloidal gold immunochromatography assay to detect human chorionic gonadotropin (hCG) in urine at cut-off 25 mIU/ml. When hCG concentration is higher than the cut-off, it will bind to rat anti ß-hCG Mab which is labelled by colloidal gold. As the sample migrates on the nitrocellulose matrix of test strip by tomographic action, the complexes of detector antibody with ßhCG are separately captured to a-hCG antibody that has been immobilized on test strip, a red line appears in test zone (T) and the test result is positive. When hCG concentration is lower than the cut-off, there is no red line shows in test zone (T) and test result is negative. There is goat anti-mouse IgG polyclonal antibody immobilized in nitrocellulose filter membrane control zone (C) that bind to rat anti ß-hCG Mab labelled by colloidal gold. When proper amount sample is applied a red line will appear in control zone (C).
10. Performance Characteristics
A. Analytical performance
- a. Precision/Reproducibility/Sensitivity
5
Negative urine was spiked with hCG standard (Traceable to the 4th WHO) to hCG concentrations of 0, 12.5, 18.75, 22.5, 25, 50, 100 and 200mIU/mL. The spiked samples were measured in replicates using 3 different lots for each format. Tests were performed by three different operators for each sample concentration in 2 runs per day for 15 days. The results are summarized in the table below:
| hCG | Lot 1 | | Lot 2 | | Lot 3 | | Total
result | | %
Negative | %
Positive |
|---------------------------|-------|----|-------|----|-------|----|-----------------|----|---------------|---------------|
| Concentration
(mIU/mL) | - | + | - | + | - | + | - | + | | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 21 | 9 | 24 | 6 | 23 | 7 | 68 | 22 | 76 | 24 |
| 22.5 | 1 | 29 | 1 | 29 | 0 | 30 | 2 | 88 | 2 | 98 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
Strip format
Cassette format
| hCG | Lot 1 | | Lot 2 | | Lot 3 | | Total
result | | %
Negative | %
Positive |
|---------------------------|-------|----|-------|----|-------|----|-----------------|----|---------------|---------------|
| Concentration
(mIU/mL) | - | + | - | + | - | + | - | + | | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 23 | 7 | 22 | 8 | 25 | 5 | 70 | 20 | 78 | 22 |
| 22.5 | 0 | 30 | 1 | 29 | 3 | 27 | 4 | 86 | 4 | 96 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
Midstream format
| hCG
Concentration
(mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total
result | | %
Negative | %
Positive |
|----------------------------------|-------|----|-------|----|-------|----|-----------------|----|---------------|---------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 22 | 8 | 23 | 7 | 26 | 4 | 71 | 19 | 79 | 21 |
| 22.5 | 2 | 28 | 1 | 29 | 2 | 28 | 5 | 85 | 6 | 94 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
6
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
|---|---|---|---|---|---|---|---|---|---|---|
| ----- | --- | ---- | --- | ---- | --- | ---- | --- | ---- | --- | ----- |
Based on the above results, the sensitivity of WHOLEPOWER® Pregnancy Rapid Test is demonstrated to be 25 mIU/mL.
b. Linearity/assav reportable range:
Linearity is not applicable since this is a qualitative test.
c. Hook effect test:
Negative urine samples were spiked with varying hCG concentrations (62500, 125000, 250000, 500000, 1000000 and 2000000 mIU/mL). All tested concentrations gave a positive result. The results demonstrated that no hook effect was observed at hCG concentrations ranging from 62500 to 2000000 mIU/mL.
d. Traceability, Stability, Expected values (controls, calibrators, or methods): WHOLEPOWER® Pregnancy Rapid Test is calibrated against reference material traceable to WHO International Standard 4th edition.
A shelf-life stability test of the devices was performed by accelerated testing. The results showed that the devices were stable for 24 months when stored at 4~30℃ in the sealed foil pouch. Real time stability studies are on going.
e. Specificity and cross reactivity
To evaluate specificity and cross-reactivity, negative and positive urine samples (12.5 mIU/mL and 25 mIU/mL) were spiked with various concentrations of glycoprotein hormones LH, FSH, TSH and hCG ß-core fragment. The results showed that there is no interference at 500 mIU/mL LH, 1000 mIU/mL FSH, 1000 mIU/L TSH and 2000,000 pmol/L hCG ß-core fragment for both negative and positive urine samples.
f. Interfering substance
To evaluate the potential for interference by certain exogenous compounds, each interfering substance was prepared by diluting stock interfering material to the desired concentration. Urine samples containing 12.5 mIU/mL and 25 mIU/mL hCG were spiked with the interfering substance to obtain the desired test concentration. No interferences were observed from exogenous compounds at the following concentrations for both negative and positive hCG urine samples.
| Substances | Concentration |
|---|---|
| Acetaminophen | 20mg/dL |
| Acetoacetic Acid | 2000mg/dL |
| Asorbic Acid | 20mg/dL |
| B-hydroxybutyrate | 2000mg/dL |
| Caffeine | 20mg/dL |
| Ephedrine | 20mg/dL |
| Gentisic Acid | 20mg/dL |
| Phenylpropanolamine | 20mg/dL |
7
| Salicylic Acid | 20mg/dL |
|---|---|
| Phenothiazine | 20mg/dL |
| EDTA | 80mg/dL |
| Acetylsalicylic Acid | 20mg/dL |
| Benzoylecgonine | 10mg/dL |
| Cannabinol | 10mg/dL |
| Codeine | 6ug/dL |
| Ethanol | 1.0% |
| Methanol | 10% |
| Albumin | 2000mg/dL |
| Glucose | 2000mg/dL |
| Bilirubin | 2mg/dL |
| Atropine | 20mg/dL |
| Estriol-17-beta | 1400ug/dL |
| Hemoglobin | 500mg/dL |
| Pregnanediol | 1500ug/dL |
| Thiophene | 20mg/dL |
| Ampicillin | 20mg/dL |
| Tetracycline | 20mg/dL |
| Ketone | 20mg/dL |
To evaluate potential interference from changes in pH, urine samples containing 12.5 mIU/mL and 25 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9. The results indicated that changes in pH range of 4~9 do not interfere in the results that were either positive or negative for hCG.
To evaluate potential interference from changes in specific gravity, urine samples containing 12.5 mIU/mL and 25 mIU/mL hCG were tested at density values ranging from 1.002, 1.007, 1.012, 1.018, 1.025 and 1.032. The results indicated that changes in specific gravity do not interfere in the results that were either positive or negative for hCG.
B. Method comparison study
Method comparison with predicate device
The performance of the new device was compared to the predicate test. Urine samples were collected from 120 women presenting to test for pregnancy at OB/GYN Physician's offices. Approximately half of the 120 women were suspected to be pregnant and most of them are in the early stage of less than 5 weeks. All samples were tested by two different health professionals for each format at each of the 3 OB/GYN Physician's offices for a total of 18 operators with the proposed and the predicate devices.
| Strip Format | Predicate device | ||
|---|---|---|---|
| Positive | Negative | ||
| WHOLEPOWER® | |||
| Rapid Pregnancy Test | Positive | 63 | 1 |
| Negative | 0 | 56 |
8
| Cassette | Predicate device | ||
|---|---|---|---|
| Positive | Negative | ||
| WHOLEPOWER® | |||
| Rapid Pregnancy Test | Positive | 64 | 0 |
| Negative | 0 | 56 |
| Midstream | Predicate device | ||
|---|---|---|---|
| Positive | Negative | ||
| WHOLEPOWER® | |||
| Rapid Pregnancy Test | Positive | 64 | 0 |
| Negative | 0 | 56 |
The above results indicate an over 98% agreement between the proposed and the predicate.
C. Lay person study:
300 women's individual pregnancy status was self-tested, varying educational and occupational backgrounds from three sites were chosen for the study. Each subject tested her own urine sample using the candidate device according to the package insert. Each subject also provided a sample for professional testing with the candidate device as well. Summary
| WHOLEPOWER Pregnancy Rapid Test
| Strip | Professional | ||
|---|---|---|---|
| + | - | ||
| Lay person | + | 53 | 0 |
| - | 1 | 46 | |
| WHOLEPOWER Pregnancy Rapid Test | |||
| Cassette | Professional | ||
| + | - | ||
| Lay person | + | 48 | 0 |
| - | 0 | 52 |
| WHOLEPOWER Pregnancy Rapid Test | Professional | ||
|---|---|---|---|
| Midstream | + | - | |
| Lay person | + | 40 | 0 |
| - | 1 | 59 |
From the above tables, the lay person results showed 100% positive and >97% negative conformity with the professional results.
Each lay person was given a questionnaire to assess the readability of the labeling. The results of the questionnaire reflected that the consumers found the test easy to
9
use and that they did not have trouble understanding the labeling and interpreting the results.
11. Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.