(217 days)
Lia Pregnancy Test is intended for non-professional, over-the-counter use for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
The Lia Pregnancy Test is an in vitro diagnostic device for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. The method employs a unique combination of monoclonal-dye conjugate and polyclonal-solid phase antibodies to selectively identify hCG in the test samples. The sensitivity of the test has been adjusted to 22mlU/mL. The Lia Pregnancy Test is a lateral flow chromatographic immunoassay. When a mid-stream urine sample is applied to the absorbent end, the sample enters the device by capillary action and mixes with the antibody-dye coniugate (mouse anti-beta hCG monoclonal antibody), flowing across the pre-coated (Goat anti-alpha hCG polyclonal antibody) membrane. During the test, hCG in the urine specimen reacts with the dye conjugate and forms a complex. The complex migrates along the cellulose strip to the α-hCG antibody line (T), and remains captured in the T line. As a result, a red colored band develops in the T line, indicating a positive result. If there is no hCG in the urine, there is no red band in the test zone, indicating a negative result. The control line develops in the Control (C) zone regardless of the result.
The provided document describes the LIA Pregnancy Test, an over-the-counter device for the qualitative identification of elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
Here's an analysis of the acceptance criteria and the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Analytical Sensitivity (Limit of Detection - LoD) | The Lia Pregnancy Test exhibited 100% detection of WHO #5 hCG-spiked samples at 22 mIU/mL and 25 mIU/mL and detected 50% of hCG-spiked samples with concentrations at 14 mIU/mL. |
| Precision/Reproducibility | The Lia Pregnancy Test exhibited reproducibility of results (sero-negative and hCG seropositive members) across a multi-kit lot, multi-operator, and multi-day study using a 12-member hCG-spiked urine panel. |
| Cross-reactivity | Neither hLH (human luteinizing hormone), hFSH (human follicle-stimulating hormone), nor hTSH (human thyroid-stimulating hormone) affected the correct call of sero-negative and hCG sero-positive urine samples in the Lia Pregnancy Test when challenged with a relevant dose. |
| Interfering Substances | The presence of a wide array of potentially interfering substances (not specified, but likely common urinary components or medications) failed to affect the correct call rates of sero-negative and hCG seropositive samples on the Lia Pregnancy Test. |
| Stability/Shelf Life | Data supports an 18-month shelf life claim based on ambient and thermal-stress conditions (37 °C and 50 °C) testing against a panel of pedigreed urine samples. |
| Effects of Urine pH | Performance of the Lia Pregnancy Test is not affected by the pH of the urine sample. |
| Effects of Urine Specific Gravity | Performance of the Lia Pregnancy Test was not affected by the specific gravity of the urine samples, either above or below the normal range (1.003 to 1.036). |
| High Dose Hook Effect (Prozone) | The Lia Pregnancy Test does not exhibit prozone activity from 25 to 500,000 mIU/mL concentrations of hCG. |
| Beta hCG Core Fragment Reactivity testing | The Lia Pregnancy Test detects ßhCGcf at concentrations >1000 pmol/L and detects low- and high-titer intact hCG even when ßhCGcf is present. |
| Lay-user Usability (Conformity between user and staff interpretation) | 98.7% conformity between user interpretation of the Lia Pregnancy Test and clinical staff interpretation of the Lia Pregnancy Test. |
| Lay-user Usability (Conformity between staff interpretation and standard of care) | 100% conformity between clinical staff interpretation of the Lia Pregnancy Test and the standard of care (predicate device results). |
| Lay-user Usability (Correct identification of positive/negative results in blinded study) | 100% of 15 lay-users correctly identified positive and negative results in a blinded study with samples at defined hCG concentrations (2, 33, and 100 mIU/mL) on three different lots. |
| Lay-user Usability (User feedback on instructions clarity) | 98% of lay-users said the printed instructions were clear and usable. |
| Lay-user Usability (User confidence in correct performance) | 91% of participants were confident they had performed the test correctly. |
| Lay-user Usability (Perceived ease of use) | 98% said it was easy to use the test. |
2. Sample Sizes and Data Provenance:
- Test Set (Clinical Performance Data):
- Lay-user usability studies: Two studies with 174 lay-user consumers between the ages of 18-49.
- Clinical Study: N = 153 women, attending four different women's health clinics. Approximately half were suspected pregnant.
- Blinded Lay-user study: 15 women performed simulated mid-stream tests.
- Data Provenance: The document does not explicitly state the country of origin. Given the FDA oversight, it's typically understood to be U.S. data unless otherwise specified. The clinical studies were conducted at "4 women's health clinics," implying prospective data collection for the purpose of the study. The non-clinical performance data (e.g., LoD, cross-reactivity) uses hCG-spiked urine panels or pedigreed urine samples, which are laboratory-controlled.
3. Number of Experts and Qualifications:
- Clinical Study: "Clinical staff member(s)" examined and reported their interpretation of Lia Pregnancy Test results. The number and specific qualifications (e.g., radiologist with 10 years of experience) are not explicitly stated. However, for in-vitro diagnostic products like pregnancy tests, "clinical staff" typically refers to trained medical professionals or laboratory personnel.
- Non-clinical studies: Experts were involved in establishing the ground truth (e.g., creating hCG-spiked samples, performing predicate device testing), but the number and specific qualifications are not detailed.
4. Adjudication Method:
- Clinical Study: The study involved a comparison between "user interpretation of the Lia Pregnancy Test", "clinical staff interpretation of the Lia Pregnancy Test", and the "standard of care" (predicate device results by a professional). This implies a direct comparison, but a formal adjudication method (like 2+1 or 3+1 consensus) for disagreements is not explicitly described. However, the "conformity between the staff interpretation of the Lia Pregnancy and the standard of care is 100%" suggests the predicate device's result was the definitive truth in that comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- An MRMC study was not explicitly stated as a comparative effectiveness study in the traditional sense for improving human reader performance with AI assistance. This device is a standalone diagnostic test for lay-users. The studies focused on demonstrating that lay-users could accurately interpret the device results, and that these interpretations aligned with professional interpretations and a predicate device. The "multi-reader" aspect is covered by the multiple lay-users interpreting the tests. There is no AI component mentioned in the document.
6. Standalone Performance Study:
- Yes, a standalone performance study was done. The entire series of non-clinical performance tests (e.g., Limit of Detection, Reproducibility, Cross-reactivity, Interfering Substances, Stability, etc.) are demonstrations of the algorithm/device's standalone performance under various conditions without human interpretation bias.
- Additionally, the clinical study's "conformity between the staff interpretation of the Lia Pregnancy and the standard of care is 100%" demonstrates the device's performance when interpreted by trained professionals, validating its output. The blinded lay-user study (100% correct identification of positive/negative results) also serves as a standalone performance assessment interpreted by the intended user.
7. Type of Ground Truth Used:
- Non-clinical studies: The ground truth for these studies was established using known concentrations of hCG (e.g., WHO #5 reference material for LoD) or pedigreed urine samples with established characteristics (e.g., sero-negative, sero-positive, pH, specific gravity, presence of interferents, ßhCGcf concentrations).
- Clinical studies: The ground truth for determining pregnancy status was the predicate device's result as tested by a professional in a clinical lab (referred to as "standard of care").
8. Sample Size for the Training Set:
- The document does not mention a training set sample size. This is because the Lia Pregnancy Test is described as an immunochromatographic device, not an AI/ML-driven device that requires traditional "training data" in the machine learning sense. Its design and performance are based on biochemical reactions and physical principles, which are verified through the outlined performance testing.
9. How the Ground Truth for the Training Set was Established:
- As the device is not an AI/ML system requiring a quantifiable training set, this question is not applicable in the context of the provided document. The ground truth for verification and validation studies was established as described in point 7.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The FDA text is in blue, with "FDA" in a square and the rest of the text in a rectangular shape.
July 27, 2018
LIA Diagnostics Anna Couturier Official Correspondent 1015 Chestnut St Suite 1401 Philadelphia, Pennsylvania 19107
Re: K171136
Trade/Device Name: LIA Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: October 23, 2017 Received: October 23, 2017
Dear Anna Couturier:
This letter corrects our substantially equivalent letter of November 20, 2017.
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. 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.
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
{1}------------------------------------------------
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
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 medical devices and radiation-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,
Courtney H. Lias -S
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
K171136
Device Name
Lia Pregnancy Test
Indications for Use (Describe)
Lia Pregnancy Test is intended for non-professional, over-the-counter use for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
Type of Use (Select one or both, as applicable)
| Exemption Under Part 503.44(a) Criteria - Domestic Septage | |
|---|---|
| ✓ | One-Time Occurrence Under Part 503.44(b) Criteria - Site Specific |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
LIA Diagnostics 1015 Chestnut Street Suite 1401 Philadelphia, PA 19107
510(k) SUMMARY For K171136 Lia Pregnancy Test
Submitter Information:
LIA Diagnostics, Inc. 1015 Chestnut Street Suite 1401 Philadelphia, PA 19107
Contact Person: Anna Couturier Telephone Number: 717-799-7795
Date Prepared: November 17, 2017
Device Name:
| Proprietary Name: | |
|---|---|
| Classification Name: | Kit, test, pregnancy, hCG, over-the-counter |
| Common Name: | Lia Pregnancy Test |
| CFR Number: | 21 CFR 872.1155 |
| Device Class: | II |
| Product Code: | LCX |
Predicate Device:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| OSOM hCG Urine Test | k9741 59 Sekisui Diagnostics |
Table 1. Predicate device information
Description of Device:
The Lia Pregnancy Test is an in vitro diagnostic device for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
The method employs a unique combination of monoclonal-dye conjugate and polyclonal-solid phase antibodies to selectively identify hCG in the test samples. The sensitivity of the test has been adjusted to 22mlU/mL. The Lia Pregnancy
{4}------------------------------------------------
Test is a lateral flow chromatographic immunoassay. When a mid-stream urine sample is applied to the absorbent end, the sample enters the device by capillary action and mixes with the antibody-dye coniugate (mouse anti-beta hCG monoclonal antibody), flowing across the pre-coated (Goat anti-alpha hCG polyclonal antibody) membrane. During the test, hCG in the urine specimen reacts with the dye conjugate and forms a complex. The complex migrates along the cellulose strip to the α-hCG antibody line (T), and remains captured in the T line. As a result, a red colored band develops in the T line, indicating a positive result. If there is no hCG in the urine, there is no red band in the test zone, indicating a negative result. The control line develops in the Control (C) zone regardless of the result.
Indications for Use:
Lia Pregnancy Test is intended for non-professional, over-the-counter use for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
The Lia Pregnancy Test is intended for Over-the-Counter use.
Identification of Risk Analysis Method
Risk analysis was performed on the Lia Pregnancy Test utilizing an FMEA process based on ISO 14971:2012. The results of the risk analysis performed on the Lia Pregnancy Test concluded that all device design controls and process controls will be able to mitiqate known potential failures and effects. In addition, usability and performance testing were performed to mitigate other potential risks.
Substantial Equivalence:
| ELEMENT | PROPOSED DEVICE:Lia Pregnancy Test | PREDICATE DEVICE:OSOM hCG Urine Test | DIFFERENCESWITHPREDICATEDEVICE |
|---|---|---|---|
| 510(k) | K171136 | K974159 | |
| Indications forUse | Lia Pregnancy Test isindicated for use intendedfor non-professional, over-the-counter use for thequalitative identification ofthe elevated levels ofhuman ChorionicGonadotropin (hCG) inurine to aid in thedetermination ofpregnancy. | For the qualitativedetermination of humanchorionic gonadotropin(hCG) in urine for theearly detection ofpregnancy. | Predicateintended for POC(point-of-care). |
{5}------------------------------------------------
| Specimen | Urine | Urine | Same |
|---|---|---|---|
| Methodology | ImmunochromatographicAssay | ImmunochromatographicAssay | Same |
| Time to Result | 5 minutes | 5 minutes | Same |
| AnalyticalSensitivity | 25mIU/mL | 25mIU/mL | Same |
| Results | Qualitative | Qualitative | Same |
| MaterialComposition | • Assay substrate – Onecontiguous cellulose webfor sample pad, conjugatepad, test strip andabsorbent wick• Antibody –Mouse monoclonal, goatpolyclonal | • Cover - plastic• Assay substrate –Cellulose samplecollection pad, glass fiberconjugate pad,nitrocellulose test strip,cellulose absorbent wick• Antibody –mouse monoclonal, rabbitpolyclonal | Membranematerial of Lia iscellulose, notnitrocellulose, likethe membrane ofthe predicate.Both substratesare inert and donot affect the testresults. |
| MaterialCompatibility | Biocompatibility meetsrequirements | Biocompatibility meetsrequirements | None |
| Targetpopulation | Traditional and normalfemales for determinationof pregnancy | Traditional and normalfemales fordetermination ofpregnancy | Same |
| Devicedesign | Handheld, mid-streamdesign. Lateral flow teststrip housed inside ahydrophobic cellulosehousing with a viewingwindow for resultsinterpretation. | Lateral flow dipstick teststrip | |
| Performance | Use friendly interface,easy to operate | Use friendly interface,easy to operate | |
| Sterility | Device provided non-sterile | Device provided non-sterile | |
| ChemicalSafety | There are no hazardouschemicals containedwithin this kit at | There are no hazardouschemicals containedwithin this kit at | |
| concentrations that areconsidered hazardous topersonal health and/or theenvironment. | concentrations that areconsidered hazardous topersonal health and/orthe environment. | ||
| Compatibilitywithenvironmentand otherdevices | The system is used insidebuildings. Interaction withother devices is notperformed | The system is usedinside buildings.Interaction with otherdevices is not performed | |
| Used at: | Home | Point of care | |
| Weight | 2.125g | .29 g | |
| Dimensions,housing (cm.)HxWxL | .38 x 5.5 x 15.5 | N/A | Predicate is a |
| test strip only | |||
| Dimensions,test strip (cm.HxWxL) | .035 x 3.7 x 17.5 | 10 x .4 x .1 | |
| Operatingtemperature | +59°F to +93°F (+15°C to+34°C) | +59°F to +86°F (+15°Cto +30°C) | |
| Humidity | Operating, 20-76% | Operating, 15% to 75% | |
| Storagetemperature | 59F to 86F (1 5C to30C),in foil pouch | 59F to 86F (1 5C to30C), | |
| TechnologyPrinciple | dyed lateral-flowimmunoassay | dyed latex-based lateral-flow immunoassay | |
| Format | Cassette (non-plastic) | Dipstick | |
| Results | Qualitative | Qualitative | |
| ResultsInterpretation | Visual | Visual | |
| SpecimenType | Human urine | Human urine | |
| SpecimenApplication | Mid-stream | Dipstick | |
| Cut-off Value | 25 mlU/ml | 25 mIU/ml | |
| Traceability | WHO InternationalStandard #5 | WHO InternationalStandard #3 | |
| QualityControl | Built-in, internal control | Built-in, internal control |
{6}------------------------------------------------
Table 2. Substantial equivalence
{7}------------------------------------------------
| Differences | |||
|---|---|---|---|
| Lia Pregnancy Test | Predicate Device | ||
| Test Format | Mid-stream format | Dipstick format | |
| Test stripcomposition | One contiguous piece ofcellulose | Cellulose samplecollection pad, glassfiber conjugate pad,nitrocellulose test strip | |
| Used at | Home | Point-of-Care |
Table 3. Differences between the Lia Pregnancy Test and legally marketed predicate
Minor differences exist between the Lia Pregnancy Test and the predicate device. The only differences are in the housing material and membrane of the test strip, neither of which affect the immunochromatographic results. These minor differences do not impact substantial equivalence of the Lia Pregnancy Test.
The Lia Pregnancy Test, and the predicate device. OSOM hCG Urine Test (K9741 59) use the same chemistry with essentially the same test design.
Non-Clinical Performance Data:
Because the proposed device, Lia Pregnancy Test, and the predicate device, OSOM hCG Urine Test (K9741 59) use similar materials with essentially the same test design, new biocompatibility testing or clinical testing was not required for the device to support substantial equivalence
Performance testing focused on verification of performance, and safety of the Lia Pregnancy Test. Below is a list of the standards to which testing was performed:
-
Precision/Reproducibility
- o To determine the reproducibility of the Lia Pregnancy Test using a 12-member hCG-spiked urine panel tested by multiple operators over multiple, non-consecutive days. The Lia Pregnancy Test exhibited reproducibility of results (sero-negative and hCG seropositive members) across a multi-kit lot, multi-operator and multiday study.
-
Cross-reactivity
- o To determine if the Lia Pregnancy Test was affected (i.e. crossreacted) by a relevant challenge dose of closely-related human lutieinzing hormone (hLH), human follicle stimulating hormone (hFSH) or human thyroid stimulating hormone (hTSH). Neither hLH, hFSH nor hTSH affect the correct call of sero-negative and hCG sero-positive urine samples in the Lia Pregnancy Test.
{8}------------------------------------------------
-
Interfering Substances
- o To determine if the Lia Pregnancy Test was affected by potentially interfering substances which may be found in human urine. The study assessed interference on both sero-negative and hCG seropositive samples. The presence of a wide array of potentially interfering substances which could be found in human urine failed to affect the correct call rates of sero-negative and hCG seropositive samples on the Lia Pregnancy Test.
-
Limit of Detection
- To determine the limit of detection (LoD) of the Lia Pregnancy Test using WHO #5 reference material. The Lia Pregnancy Test exhibited 100% detection of WHO #5 hCG-spiked samples at 22 and 25 mlU/ml and detected 50% of hCG-spiked samples with concentrations at 14 mIU/ml
-
Stability/Shelf Life
- o To investigate the Lia Pregnancy Test device's stability, the product was stored at ambient (anticipated end-user storage conditions) and thermal-stress conditions (37 °C and 50 °C) and tested against a panel of pedigreed urine samples. Data supports an 18-month shelf life claim
-
Effects of Urine pH
- To determine if the performance of the Lia Pregnancy Test was affected by the pH of urine samples. Performance of the Lia Pregnancy Test is not affected by pH of the urine sample.
-
Effects of Urine Specific Gravity
- o To determine if the performance of the Lia Pregnancy Test was affected by the specificity gravity of urine samples. The normal range for specific gravity of urine is 1 .003 to 1 .036. In this study, performance of the Lia Pregnancy Test was not affected by the specific gravity of the urine samples, either above or below, the normal range
-
High Dose Hook Effect (aka prozone)
- To determine if the Lia Pregnancy Test exhibits evidence of o prozone (aka "hook effect") behavior when challenged with a high concentration of analyte (hCG). In immunoassay tests which have prozone issues, false negative results could be reported despite the analyte being present in the sample. Results show the Lia Preqnancy Test does not exhibit prozone activity from 25 to 500,000 mIU/ml concentrations of hCG.
-
Beta hCG Core Fraqment Reactivity testing
- o To determine how the Lia Pregnancy Test how was affected by the beta-core fragment of hCG, a hCG-like molecule which may be present at high concentrations during pregnancy. The Lia Pregnancy Test detects ßhCGcf at concentrations >1000 pmol/L and detects low- and high-titer intact hCG even when ßhCGcf is present.
{9}------------------------------------------------
Along with the above tests, Stability of results, shipping stability, and environmental factors testing were also conducted and demonstrated compliance to specifications.
The results of these performance tests support the substantial equivalence of the proposed device, Lia Pregnancy Test, with the predicate device, OSOM hCG Urine Test (K974159)
Clinical Performance Data.
Professional evaluations were conducted considering the proposed device intended use, intended users, and intended use environments.
All studies were completed by lay-users and professional staff members at 4 women's health clinics. Lia performed two studies with 174 lay-user consumers between the ages of 18 – 49 to determine lay-person usability. In each study, devices from three manufacturing lots of Lia tests were used.
For the Lia Clinical Study, a total of N=1 53 women, attending four different women's health clinics, self-performed the Lia Pregnancy Test according to Package Insert instructions. Approximately half of the subjects were suspected to be pregnant. Lay-users collected a mid-stream sample on the Lia Pregnancy Test and a small aliquot in a specimen cup. The later sample was tested with the predicate device in clinical lab by a professional. The lay-user recorded their interpretation of the Lia Pregnancy Test results and then a clinical staff member examined and reported their interpretation of Lia Pregnancy Test results. Samples were randomly collected at various times throughout the day. Ages of these women ranged from 18 to 49 years.
The conformity between the user interpretation of the Lia Pregnancy Test and the staff interpretation of the Lia Pregnancy Test is 98.7%. The conformity between the staff interpretation of the Lia Pregnancy and the standard of care is 100%.
Data analysis shows that lay-users can successfully interpret the results, and that the test results were 100% concordant with the standard of care. In the post test questionnaire users report that the test is easy to use and the instructions are easy to understand. In the questionnaire answered after subjects used the test. 98% of lay-users said that the printed instructions were clear and usable. 91% of participants were confident that they had performed the test correctly. 98% said it was easy to use the test.
In an additional lay user study, 15 women performed simulated mid-stream tests with samples provided by Lia at defined hCG concentrations, close to the cutoff. In this study, 15 lay-users tested three different samples (2, 33, and 100mlU/mL) on three different lots of the Lia Pregnancy Test. Users were "blinded" as to sample status, and recorded their interpretation of the results. 100% of users correctly identified positive and neqative results.
{10}------------------------------------------------
As a result of clinical usability validations involving performance testing, data was gathered to support our assessment that the risk of harm has been adequately mitiqated and no unacceptable risks or unacceptable use related hazards related to the Lia Pregnancy Test were identified.
Conclusion Regarding Substantial Equivalence
The proposed device, Lia Pregnancy Test, is a pregnancy test for over-thecounter use intended for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. The Lia Pregnancy Test has the same intended use, incorporates the same fundamental technology as the predicate, uses similar material and has essentially the same design as the predicate device, OSOM hCG Urine Test (K974159)
Test data to verify the performance of the proposed device, Lia Pregnancy Test, has been provided including:
-
Precision/Reproducibility
-
Cross-reactivity
-
Interfering Substances
-
Limit of Detection
-
Stability/Shelf Life
-
Effects of Urine pH & Urine Specific Gravity
-
High Dose Hook Effect
- . Beta hCG Core Fragment
The results of this performance testing, combined with the design and intended use comparison with the predicate device, OSOM hCG Urine Test (K974159), support substantial equivalence to, the predicate device, OSOM hCG Urine Test (K974159).
§ 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.