(100 days)
Not Found
No
The device description and performance studies focus on a standard immunofluorescence-based lateral flow assay for detecting hCG. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text.
No
The device is intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine specimens to aid early detection of pregnancy, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as an assay "designed to aid early detection of pregnancy" through the "qualitative detection of human Chorionic Gonadotropin (hCG) in urine specimens," which falls under the definition of a diagnostic device.
No
The device description explicitly states the test kit consists of physical components like test Cassettes and specimen transfer pipettes, indicating it is a hardware-based device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of human Chorionic Gonadotropin (hCG) in urine specimens and is designed to aid early detection of pregnancy." This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide diagnostic information (pregnancy status).
- Device Description: The description details a "qualitative immunofluorescence-based assay used to detect concentrations of 20 mIU/mL hCG or more in urine." This describes a laboratory or point-of-care test that analyzes a sample.
- Clinical Performance: The description of the clinical study, where "fresh urine specimens from patients presenting for pregnancy testing were evaluated," further confirms its use in a diagnostic context.
- Predicate Device: The mention of a "Predicate Device(s)" which is another hCG test (QuickVue+ One-Step hCG Combo test) indicates that this device is being compared to other devices used for in vitro diagnostic purposes.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sofia hCG FIA is an immunofluorescence-based lateral flow assay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine specimens and is designed to aid early detection of pregnancy.
The test is intended for prescription use only, including use at point-of-care sites.
Product codes (comma separated list FDA assigned to the subject device)
JHI
Device Description
The test kit consists of individually packaged test Cassettes-each containing monoclonal murine antibodies for the capture and detection of hCG; disposable specimen transfer pipettes; and a package The test is a qualitative immunofluorescence-insert. based assay used to detect concentrations of 20 mIU/mL hCG or more in urine.
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
prescription use only, including use at point-of-care sites.
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)
Numerous studies were undertaken to document the performance characteristics and substantial equivalence of the test to the predicate device. These studies included the following:
- a. Analytical Performance
-
- Reproducibility
The reproducibility of the Sofia hCG FIA was evaluated at three (3) different laboratories. Three (3) different operators at each site tested a series of coded, contrived samples, prepared in negative urine, ranging from a low negative (5 mlU/mL) to a moderate positive (25 mlU/mL) hCG. For each level a total of 90 replicates were tested over five (5) different days at each site. The results at each site agreed 100% with the expected results for these levels. There were no significant differences observed within run, between runs, or between sites.
- Reproducibility
-
- High Dose Hook Effect
A high dose hook effect study was performed by spiking high levels of hCG concentrations 0 to 500,000 mlU/mL into negative urine and evaluating the test results. Positive results were observed up to 500,000 mlU/mL hCG. Therefore no hook effect was observed for urine samples with hCG concentrations up to 500,000 mIU/mL.
-
- Detection Limit
The sensitivity of the device was tested by spiking pooled male urine with varying concentrations (0 to 100 mlU/mL) of hCG traceable to WHO International 4th Standard. The positive/negative threshold at which 100% of the samples tested positive was confirmed at 20 mIU/mL hCG.
- Detection Limit
-
- Analytical Specificity
Interference and cross-reactivity studies were performed by adding known amounts of chemical substances, urine analytes, hormones, and microorganisms to pooled negative urine. No cross-reactivity or interference was observed for the substances and microorganisms listed below:
- Analytical Specificity
b. Clinical Performance:
A multi-center clinical study was conducted to establish the performance of the Sofia hCG FIA compared to results obtained from another commercially available qualitative test. This study was conducted by health care personnel at five (5) distinct sites in various geographical regions within the United States. In this multi-center, point-of-care (POC) field trial, 974 fresh urine specimens, collected from patients presenting for pregnancy testing, were evaluated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Agreement = >99% (176/177) (95% Cl=97-100%)
Negative Agreement = >99% (795/797) (95% Cl=99-100%)
Overall Agreement = >99% (971/974) (95% Cl=99-100%)
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.
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.
0
AUG 2 2013
510(k) SUMMARY
Date Prepared:
Type of Test: Qualitative fluorescent hCG immunoassay
July 29, 2013
Applicant: Quide! Corporation 10165 McKellar Court San Diego, California 92121 Telephone: 858-552-7908 Fax: 858-646-8045
Submission Contact: John D. Tamerius, Ph.D.
Sofia® hCG FIA Proprietary and Established Names:
Device Classification:
| Product Code: | JHI |
|---|---|
| Classification: | Class II |
| Regulatory Section: | 21 CFR 862.1155(a), Human |
| Chorionic Gonadotropin (HCG) | |
| test system intended for the early | |
| detection of pregnancy | |
| Panel: | Clinical Chemistry (75) |
Intended Use: The Sofia hCG FIA is an immunofluorescence-based lateral flow assay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine specimens and is designed to aid early detection of pregnancy.
The test is intended for prescription use only, including use at point-of-care sites.
Device Description: The test kit consists of individually packaged test Cassettes-each containing monoclonal murine antibodies for the capture and detection of hCG; disposable specimen transfer pipettes; and a package The test is a qualitative immunofluorescenceinsert. based assay used to detect concentrations of 20 mIU/mL hCG or more in urine.
1
1 - 6
Comparison with Predicate:
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Features | Sofia hCG FIA | QuickVue+ One-Step hCG |
| Combo test (K973858) | ||
| Intended Use | The Sofia hCG FIA is an | |
| immunofluorescence-based | ||
| lateral flow assay intended for | ||
| the qualitative detection of | ||
| human Chorionic | ||
| Gonadotropin (hCG) in urine | ||
| specimens and is designed to | ||
| aid early detection of | ||
| pregnancy. | ||
| The test is intended for | ||
| prescription use only, | ||
| including use at point-of-care | ||
| sites. | The QuickVue+ One-Step hCG | |
| Combo test is a one-step | ||
| immunoassay intended for the | ||
| qualitative detection of human | ||
| Chorionic Gonadotropin (hCG) | ||
| in serum or urine for the early | ||
| detection of pregnancy. The | ||
| test is intended for use by | ||
| healthcare professionals. | ||
| Specimen Type | Urine | Urine/Serum |
| Format | Cassette | Cassette |
| Test Principle | Immunofluorescence-based | |
| lateral flow assay | Lateral flow immunoassay | |
| Instrument | Sofia Analyzer | No instrument; visually-read |
| assay | ||
| Read Result Time | Approximately 3 minutes | 3 minutes for urine |
| Analytical Sensitivity | 20 mIU/mL for urine | 20 mIU/mL for urine |
| Traceability | WHO International Standard | |
| 4th Edition 75/589 | WHO International Standard 3rd | |
| Edition 75/537 | ||
| Storage | 15 to 30°C | 15 to 30°C |
.
2
Test Principle:
The Sofia hCG FIA is an immunofluorescence-based lateral flow test for use with the Sofia Analyzer. The test uses a pair of monoclonal murine antibodies specific to the beta subunit of hCG to capture and detect hCG. The beta subunit was chosen to ensure specificity as the alpha subunit is nearly identical to the alpha subunit found in LH, FSH and TSH.
To perform the test, a urine specimen is collected and dispensed into the Sample Well on the Test Cassette. The Cassette is placed inside of the Sofia Analyzer for an automatically defined development time. The Sofia Analyzer then scans the test strip and analyzes the fluorescent signal, using method-specific algorithms. The Sofia Analyzer then displays the test result (Positive, Negative, or Invalid) on the screen, and optionally prints the results on an integrated printer.
Summary of Performance Data:
Numerous studies were undertaken to document the performance characteristics and substantial equivalence of the test to the predicate device. These studies included the following:
- a. Analytical Performance
-
- Reproducibility
-
The reproducibility of the Sofia hCG FIA was evaluated at three (3) different laboratories. Three (3) different operators at each site tested a series of coded, contrived samples, prepared in negative urine, ranging from a low negative (5 mlU/mL) to a moderate positive (25 mlU/mL) hCG. For each level a total of 90 replicates were tested over five (5) different days at each site. The results at each site agreed 100% with the expected results for these levels. There were no significant differences observed within run, between runs, or between sites.
- High Dose Hook Effect
A high dose hook effect study was performed by spiking high levels of hCG concentrations 0 to 500,000 mlU/mL into negative urine and evaluating the test results. Positive results were observed up to 500,000 mlU/mL hCG. Therefore no hook effect was observed for urine samples with hCG concentrations up to 500,000 mIU/mL.
3
-
- Detection Limit
The sensitivity of the device was tested by spiking pooled male urine with varying concentrations (0 to 100 mlU/mL) of hCG traceable to WHO International 4th Standard. The positive/negative threshold at which 100% of the samples tested positive was confirmed at 20 mIU/mL hCG.
- Detection Limit
-
- Analytical Specificity
Interference and cross-reactivity studies were performed by adding known amounts of chemical substances, urine analytes, hormones, and microorganisms to pooled negative urine. No cross-reactivity or interference was observed for the substances and microorganisms listed below:
- Analytical Specificity
| Item | Substance/Microorganism | Concentration | ||||
|---|---|---|---|---|---|---|
| Chemical Substances | ||||||
| 1 | Acetaminophen | 20 mg/dL | ||||
| 2 | Acetoacetic Acid | 1,600 mg/dL | ||||
| 3 | Acetylsalicylic Acid | 20 mg/dL | ||||
| 4 | Ampicillin | 2 mg/dL | ||||
| 5 | Ascorbic Acid | 20 mg/dL | ||||
| 6 | Atropine | 20 mg/dL | ||||
| 7 | β-Hydroxybutyrate | 2,000 mg/dL | ||||
| 8 | Benzoylecgonine | 8 mg/dL | ||||
| 9 | Bovine Serum | 10 mg/dL | ||||
| 10 | Caffeine | 20 mg/dL | ||||
| 11 | Cannabinol | 10 mg/dL | ||||
| 12 | Cellulose | 500 mg/dL | ||||
| 13 | Citric Acid | 500 mg/dL | ||||
| 14 | Clomiphene | 100 mg/dL | ||||
| 15 | Cow's Milk | 9 mg/dL | ||||
| 16 | DMSO | 0.90% | ||||
| 17 | EDTA | 80 mg/dL | ||||
| 18 | Ephedrine | 18 mg/dL | ||||
| 19 | Ethanol | 0.80% | ||||
| 20 | Gentisic Acid | 20 mg/dL | ||||
| 21 | Methanol | 0.90% | ||||
| 22 | Phenothiazine | 20 mg/dL | ||||
| 23 | Phenylpropanolamine | 20 mg/dL | ||||
| 24 | Salicylic Acid | 20 mg/dL | ||||
| 25 | Tetracycline | 20 mg/dL | ||||
| 26 | Theophylline | 20 mg/mL | ||||
| 27 | Uric Acid | 18 mg/dL | ||||
| Urine Substances | ||||||
| 28 | Albumin (serum) | 2,000 mg/dL | ||||
| 29 | Bilirubin | 1 mg/dL |
4
| Item | Substance/Microorganism | Concentration |
|---|---|---|
| 30 | Glucose | 2,000 mg/dL |
| 31 | Haptoglobin | 1 mg/dL |
| 32 | Hemoglobin | 1 mg/dL |
| 33 | Human Anti-Mouse Antibodies | 2.85 ng/mL |
| 34 | Myoglobin | 1 mg/dL |
| 35 | Rheumatoid Factor | 1.08 IU/mL |
| 36 | Serum (negative human) | 1% |
| 37 | Urine Peroxide | 10 mg/dL |
| 38 | Urine pH | 5-9 |
| 39 | Urine Specific Gravity | 1.005-1.037 |
| Hormones | ||
| 40 | hLH | 450 mIU/mL |
| 41 | hFSH | 900 mIU/mL |
| 42 | hTSH | 1,000 mIU/mL |
| 43 | Estriol 17-beta | 28,000 $ μg $ /dL |
| 44 | Pregnanediol glucuronide | 45,000 $ μg $ /dL |
| 45 | β-core fragment, hCG | 5.1 x 105 pmol/L |
| Microorganisms | ||
| 46 | Escherichia coli | 2.61 x 108 CFU/mL |
| 47 | Streptococcus agalactiae (Group B) | 2.50 x 107 CFU/mL |
| 48 | Chlamydia trachomatis | 1 x 107 IFU/mL |
| 49 | Candida albicans | 1.07 x 107 CFU/mL |
b. Clinical Performance:
A multi-center clinical study was conducted to establish the performance of the Sofia hCG FIA compared to results obtained from another commercially available qualitative test. This study was conducted by health care personnel at five (5) distinct sites in various geographical regions within the United States. In this multi-center, point-of-care (POC) field trial, 974 fresh urine specimens, collected from patients presenting for pregnancy testing, were evaluated.
Sofia hCG FIA Performance Compared to a Commercially Available Qualitative Test
| Comparator Test | Positive Agreement = >99% (176/177) | |||
|---|---|---|---|---|
| Pos | Neg | (95% Cl=97-100%) | ||
| Sofia Pos | 176 | 2 | Negative Agreement = >99% (795/797) | |
| Sofia Neg | 795 | (95% Cl=99-100%) | ||
| Total | 177 | 797 | Overall Agreement = >99% (971/974) | (95% Cl=99-100%) |
5
Image /page/5/Picture/0 description: The image shows the word "QUIDEL" in a bold, sans-serif font. The letters are all capitalized and black. A small registered trademark symbol is located to the right of the "L".
Conclusion:
These studies demonstrated the substantial equivalence of the Sofia hCG FIA for use with the Sofia Analyzer to the existing product already marketed, QuickVue+ One-Step hCG Combo test, K973858. They further demonstrated the suitability of the product for point-of-care use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Quidel Corp. C/O John D. Tamerius 10165 McKellar Ct. SAN DIEGO CA 92121
August 2, 2013
Re: K131166
Trade/Device Name: Sofia® hCG FIA Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: II Product Code: JHI Dated: July 1, 2013 Received: July 3, 2013
Dear Dr. Tamerius:
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 801); medical device reporting (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for
7
Page 2-Dr. Tamerius
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
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
8
Indications for Use
510(k) Number (if known): K131166
Device Name: Sofia® hCG FIA
Indications for Use:
The Sofia hCG FIA is an immunofluorescence-based lateral flow assay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine specimens and is designed to aid early detection of pregnancy.
The test is intended for prescription use only, including use at point-of-care sites.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnson-lyles -S 2013.08.01 08:31:34 -04'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k)___k131166 _____________________________________________________________________________________________________________________________________________________________
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