(361 days)
k96446, K093318
Not Found
No
The device description and performance studies indicate a traditional immunoassay based on chemical reactions and visual interpretation, with no mention of AI or ML.
No.
The device is a diagnostic test for pregnancy, not a therapeutic device designed to treat or prevent a disease or condition.
Yes
The device is intended to aid in the "early detection of pregnancy" by visually and qualitatively detecting human chorionic gonadotropin (hCG), which is a diagnostic purpose.
No
The device description clearly outlines physical components like a "Cassette format," "reagent strip," "coated membrane," and "dried chemical pad," indicating it is a hardware-based diagnostic test, 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 "visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen to aid in the early detection of pregnancy." This is a classic example of an in vitro diagnostic test, as it analyzes biological samples (serum or urine) outside of the body to diagnose a condition (pregnancy).
- Device Description: The description details the components of the test, which are reagents designed to interact with substances in the biological sample. This is characteristic of an IVD.
- Performance Studies: The document describes performance studies evaluating the accuracy of the test using clinical specimens. This is a standard requirement for demonstrating the effectiveness of an IVD.
- Key Metrics: The inclusion of sensitivity and specificity values, calculated from testing biological samples, further confirms its nature as an IVD.
- Predicate Devices: The mention of predicate devices, which are also IVDs (pregnancy tests and an immunoassay instrument), indicates that this device falls within the same regulatory category.
Therefore, based on the provided information, the Polymed Therapeutics' Fastep™ hCG Pregnancy Serum/Urine Test is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Polymed Therapeutics' Fastep™ hCG Pregnancy Serum/Urine Test is a rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen to aid in the early detection of pregnancy. For Professional Use Only.
The test kits are for health care professionals use including professionals at physician's office labs (POLs) or point-of-care site (POC).
Product codes (comma separated list FDA assigned to the subject device)
JHI
Device Description
The Fastep™ hCG Pregnancy Serum/Urine Test are distributed in Cassette format. Each test reagent strip contains mouse monoclonal anti-a-hCG antibody coated membrane and a dried chemical pad containing mouse monoclonal anti-B-hCG anybody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG.
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
health care professionals use including professionals at physician's office labs (POLs) or point-of-care site (POC).
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
The product performance characteristics of Polymed Therapeutics' Fastep" hCG Pregnancy Serum/Urine Test was evaluated in the blind-labeled spiked control studies and blind-labeled clinical specimen correlation study (including POLs site study).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The product performance characteristics of Polymed Therapeutics' Fastep" hCG Pregnancy Serum/Urine Test was evaluated in the blind-labeled spiked control studies and blind-labeled clinical specimen correlation study (including POLs site study). The results of these studies demonstrate Polymed Therapeutics' Fastep104 hCG Pregnancy Serum/Urine Test to be substantially equivalent to the performance characteristics of Teco's One Step Pregnancy Urine/Serum Test. Correlation studies, using 145 clinical specimen sets, produced a minimum of 98.3% accuracy.
Accuracy Results:
A. Urine sample (N=145): Sensitivity = 100.0%; Specificity = 100.0%
B. Serum sample (N=145): Sensitivity = 98.3%; Specificity = 100.0%
Sensitivity and Cross-reactivity: The Fastep™ hCG Pregnancy Serum/Urine Test detects serum or urinary hCG at a concentration of 20mlU/ml or greater. Cross-reactivity (Specificity) evaluated at negative (0 mIU/ml) and positive (20 mIU/ml) hCG specimens showed no cross-reaction.
Precision (POL sites): Lab spiked hCG urine and serum controls were used to evaluate the precision performance of Fastep™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests. 3 lots devices were tested at 3 Point-of-care sites by 9 operators.
Interference: The performance of Fastep™ hCG Serum/Urine Pregnancy test at negative and cutoff points are not affected when the pH range of urine specimens is at 3.0 to 8.5 and the specific gravity range of urine specimens is at 1.00 to 1.03. Various substances (Acetaminophen, Acetylsalicylic Acid, Albumin, Ascorbic Acid, Atropine, Bilirubin, Caffeine, EDTA, Ethanol, Gentesic Acid, Glucose, Hemoglobin, Methanol, Salicylic Acid, Triglyceride) were tested and none interfered with the assay at the concentrations tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Urine sample: Sensitivity = 100.0%; Specificity = 100.0%
Serum sample: Sensitivity = 98.3%; Specificity = 100.0%
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.
k96446, K093318
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
510(k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
JUL 1 7 2012
The Assigned 510(k) number is: K112101
Date of Summary: July 13, 2012
Common Name: hCG (Human Chorionic Gonadotropin) Pregnancy Serum/Urine Combo Test
Regulatory Information:
-
- Regulation section: 21 CFR part 862.1155, Human Chorionic Gonadotropin test system
-
- Classification: Class II
-
- Product Code: JHI, radioimmunoassay, human chorionic gonadotropin
-
- Panel: Clinical Chemistry 75
Applicant and Initial Importer:
Polymed Therapeutics, Inc. 3040 Post Oak Blvd., Ste 1110 Huston, TX 77056 Tel.: (713) 777-7088 Fax: (713) 777-7091
Contact Persons:
Primary Contact:
Mrs. Feng-Yu Lee Correspondent for this Application Polymed Therapeutics, Inc. c/o IVDD Regulatory Consultant 27001 La Paz Road Suite 266B Mission Viejo, CA 92691 Tel: (949) 951-3046 Fax: (949) 951-2042 fengyulee@ivddreg.com
Alternate Only:
Terri Wallace . Polymed Therapeutics, Inc 3040 Post Oak Blvd., Ste 1110 Huston, TX 77056 Tel .: (713) 777-7088 Fax: (713) 777-7091 terri@polymedt.com
Identification / Product Name:
Fastep™ hCG Pregnancy Serum/Urine Test
1
510(k) SUMMARY (Cont.)
Description:
The Fastep™ hCG Pregnancy Serum/Urine Test are distributed in Cassette format. Each test reagent strip contains mouse monoclonal anti-a-hCG antibody coated membrane and a dried chemical pad containing mouse monoclonal anti-B-hCG anybody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG.
Intended Use:
The Polymed Therapeutics' Fastep™ hCG Pregnancy Serum/Urine Test is rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen to aid in the early detection of pregnancy. For Professional Use Only.
The test kits are for health care professionals use including professionals at physician's office labs (POLs) or point-of-care site (POC).
Predicate Kit:
Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test is used as predicate device for Polymed Therapeutics' Fastep104 hCG Pregnancy Serum/Urine Test to compare their performance of required studies. The clinical serum specimens used for accuracy study were quantitatively confirmed by Abbott Architect i2000 instrument.
| 510(k) numbers for predicate devices are: | |
|---|---|
| Abbott Architect i2000 instrument | K093318 |
| Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Test | k96446 |
Performance:
The product performance characteristics of Polymed Therapeutics' Fastep" hCG Pregnancy Serum/Urine Test was evaluated in the blind-labeled spiked control studies and blind-labeled clinical specimen correlation study (including POLs site study). The results of these studies demonstrate Polymed Therapeutics' Fastep104 hCG Pregnancy Serum/Urine Test to be substantially equivalent to the performance characteristics of Teco's One Step Pregnancy Urine/Serum Test. Correlation studies, using 145 clinical specimen sets, produced a minimum of 98.3% accuracy.
Accuracy Results:
A. Urine sample
| Teco One-Step Combo Card Test | ||||
|---|---|---|---|---|
| + | - | Total | ||
| FastepTM | ||||
| Cassette Panel | + | 59 | 0 | 59 |
| - | 0 | 86 | 86 | |
| Total | 59 | 86 | 145 |
Sensitivity = (59 / (59+0)) x100 = 100.0%; Specificity = (86 / (86+0)) x 100 = 100.0%
2
510(k) SUMMARY (Cont.)
B. Serum sample
51 positive and 86 negative quantitative confirmed serum specimens were evaluated. The results of the accuracy finding calculated against predicate device are summarized and presented in the form of a 2x2 table (shown below):
| Teco One-Step Combo Card Test | ||||
|---|---|---|---|---|
| + | - | Total | ||
| FastepTM | ||||
| Cassette Panel | + | 58 | 0 | 58 |
| - | 1 | 86 | 87 | |
| Total | 59 | 86 | 145 |
Sensitivity = 58/(58+1)) x100 = 98.3%; Specificity = (86/(86+0)) x 100 = 100.0%
Sensitivity and Cross-reactivity
The Fastep™ hCG Pregnancy Serum/Urine Test detects serum or urinary hCG at a concentration of 20mlU/ml or greater. The test has been standardized to the WHO Fourth International Standard 75/589.
Cross-reactivity (Specificity) evaluated at negative (0 mIU/ml) and positive (20 mIU/ml) hCG specimens showed no cross-reaction:
| Compounds (level) | % Non-cross- reactivity |
|---|---|
| hCG (20 mIU/ml) | 100% |
| hLH (300 mIU/ml) | 1,500% |
| hFSH (1,000 | |
| mIU/ml) | 5,000% |
| hTSH (1,000 | |
| μIU/mL) | 5% |
Precision (POL sites)
Lab spiked hCG urine and serum controls were used to evaluate the precision performance of
Fastep™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests. 3 lots devices were 3 Point-of-care sites by 9 operators.
A. Serum controls
| Levels
(mIU/ml) | No. of
Negative | No. of
Positive | %
Negative | %
Positive |
|--------------------|--------------------|--------------------|---------------|---------------|
| 0 | 225 | 0 | 100% | 0% |
| 10 | 225 | 0 | 100% | 0% |
| 15 | 225 | 0 | 100% | 0% |
| 20 | 7 | 218 | 3.1% | 96.9% |
| 40 | 0 | 225 | 0% | 100% |
| 100 | 0 | 225 | 0% | 100% |
B. Urine controls
| Levels
(mIU/ml) | No. of
Negative | No. of
Positive | %
Negative | %
Positive |
|--------------------|--------------------|--------------------|---------------|---------------|
| 0 | 225 | 0 | 100% | 0% |
| 10 | 225 | 0 | 100% | 0% |
3
| 15 | 225 | 0 | 100% | 0% |
|---|---|---|---|---|
| 20 | 7 | 218 | 3.1% | 96.9% |
| 40 | 0 | 225 | 0% | 100% |
| 100 | 0 | 225 | 0% | 100% |
Interference
The performance of Fastep™ hCG Serum/Urine Pregnancy test at negative and cutoff points are not affected when the pH range of urine specimens is at 3.0 to 8.5 and the specific gravity range of urine specimens is at 1.00 to 1.03.
The following substances were added to hCG free and 20mIU/ml hCG spiked serum and urine samples. None of the substances at the concentration tested interfered with the assay.
| Substances | Con. in
Serum | Con. in
Urine |
|-------------------------|------------------|------------------|
| Acetaminophen | 20 mg/dl | 20 mg/dl |
| Acetylsalicylic
Acid | 20 mg/dl | 20 mg/dl |
| Albumin | 2000 mg/dl | 2000 mg/dl |
| Ascorbic Acid | 20 mg/dl | 20 mg/dl |
| Atropine | 20 mg/dl | 20 mg/dl |
| Bilirubin | 40 mg/dl | 2 mg/dl |
| Caffeine | 20 mg/dl | 20 mg/dl |
| EDTA | 80 mg/dl | 80 mg/dl |
| Ethanol | 1% | 1% |
| Gentesic Acid | 20 mg/dl | 20 mg/dl |
| Glucose | 2 g/dl | 2 g/dl |
| Hemoglobin | 125 mg/dl | 1 mg/dl |
| Methanol | 1 % | 1 % |
| Salicylic Acid | 20 mg/dl | 20 mg/dl |
| Triglyceride | 1200 mg/dl | N/A |
*: ß-core hCG level up to 8.53 pmol/L does not interfere with the assay.
Conclusion:
Of these specimen sets tested in serum and urine device, results of Accuracy, POL site study demonstrate the substantial equivalency between Polymed Therapeutics' Fastep" hCG Pregnancy Serum/Urine Test and the Teco One- Step Pregnancy Urine/Serum Test panel. It is also demonstrated that Polymed Therapeutics' Fastep™ hCG Pregnancy Serum/Urine Test is safe and effective in detecting human chorionic gonadotropin (hCG) in serum or urine sample to aid in the early determination of pregnancy.
Polymed Therapeutics, Inc
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle.
10903 New Hampshire Avenue Silver Spring, MD 20993
Polymed Therapeutics, Inc c/o Feng-Yu Lee 27001 La Paz Road Suite 266B Mission Viejo, CA 92691
JUL 17 2012
K112101 Re:
Trade Name: Fastep™ hCG Pregnancy Serum/Urine Cassette Tests Regulation Number: 21 CFR §862.1155 Regulation Name: Human chorionic gonadotropin (hcg) test system Regulatory Class: Class II Product Codes: JHI Dated: June 20, 2012 Received: July 9, 2012
Dear Feng-Yu Lee:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, 1 please note the regulation entitled, "Misbranding by reference to premarket notification" (21 prodo note the rogarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely vours.
C. Hsiung, Ph.D.
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use Form
510(k) Number (if known): K11210 |
Device Name: Polymed Therapeutics' Fastep™ hCG Pregnancy Serum/Urine Test
Indications for Use:
The Polymed Therapeutics' Fastep™ hCG Pregnancy Serum/Urine Test is a rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen to aid in the early detection of pregnancy. For Professional Use Only.
The test kits are for health care professionals use including professionals at physician's office labs (POLs) and Point-of-Care site (POC).
Prescription Use X (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 Diagnostic Devices (OIVD)
Juandria Ono
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K 112101
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