(79 days)
K 041946
Not Found
No
The device is a rapid chromatographic immunoassay for visual detection, with no mention of AI/ML in the description, intended use, or performance studies.
No
A therapeutic device is used to treat or cure a disease or condition. This device is a diagnostic tool used to detect pregnancy, not to treat it.
Yes
Explanation: The "Intended Use" states that the device is for "visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen to help in the early determination of pregnancy." This indicates that the device is used to identify a condition (pregnancy), which falls under the definition of a diagnostic device.
No
The device description clearly outlines physical components (cassette, dipstick, membrane, chemical pad, antibodies, colloidal gold conjugate) which are hardware, not software. The device is a rapid chromatographic immunoassay, a physical test kit.
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 help in the early determination of pregnancy." This involves testing a biological sample (serum or urine) in vitro (outside the body) to obtain diagnostic information.
- Device Description: The description details the components of the test strip, which are reagents designed to react with substances in the biological sample.
- Performance Studies: The document describes studies evaluating the device's performance using clinical specimens (serum and urine), which is characteristic of IVD testing.
- Key Metrics: Metrics like sensitivity and specificity are provided, which are standard performance indicators for IVD devices.
The definition of an IVD is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases or other conditions. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The Applied DNA Technologies Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen to help in the early determination of pregnancy.
The test kits are for health care professionals use including professionals at physician's office labs (POLs).
For a final Diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.
Product codes
JHI
Device Description
The Bionexia™ hCG Pregnancy Serum/Urine Test are distributed in both Cassette and Dipstick formats. Each test reagent strip contains mouse monoclonal anti-u-hCG antibody coated membrane and a dried chemical pad containing mouse monoclonal anti-ß-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)
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)
The product performance characteristics of ADT's Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests were 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 ADT's Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests to be substantially equivalent to the performance characteristics of ACON's One Step Pregnancy Urine/Serum Test.
(I) Accuracy/Comparison study indicated 100% agreement in total of 95 clinical serum specimens and 94 clinical urine specimens evaluated, the study were conducted at two POL sites. (Additionally, 20 negative and 29 positive serum & urine specimens were reevaluated at a third site and similar results were obtained.)
- Serum sample: 48 positive, 47 negative. Total 95.
- Urine sample: 47 positive, 47 negative. Total 94.
(II) Sensitivity and Cross-reactivity: The Bionexia" hCG Pregnancy Serum/Urine Test detects serum or urinary hCG at a concentration of 20 mIU/ml or greater. The test has been standardized to the WHO Fourth International Standard 75/589. Cross-reactivity study (Specificity) evaluated at negative (0 mIU/ml) and positive (20 mIU/ml) hCG specimens showed no cross-reaction with hLH, hFSH, and hTSH.
(III) Reproducibility:
- Serum controls: 100% negative at 0 mIU/ml and 10 mIU/ml; 100% positive at 20 mIU/ml, 25 mIU/ml, 30 mIU/ml, 35 mIU/ml, 40 mIU/ml, and 100 mIU/ml. Variable results between 12.5 mIU/ml and 17.5 mIU/ml.
- Urine controls: 100% negative at 0 mIU/ml and 10 mIU/ml; 100% positive at 20 mIU/ml, 25 mIU/ml, 30 mIU/ml, 35 mIU/ml, 40 mIU/ml, and 100 mIU/ml. Variable results between 12.5 mIU/ml and 17.5 mIU/ml.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The Bionexia" hCG Pregnancy Serum/Urine Test detects serum or urinary hCG at a concentration of 20mIU/ml or greater.
Accuracy/Comparison study indicated 100% agreement.
Cross-reactivity data:
- hCG (20 mIU/ml): 100% Non-cross-reactivity
- hLH (300 mIU/ml): 1,500% Non-cross-reactivity
- hFSH (1000 mIU/ml): 5,000% Non-cross-reactivity
- hTSH (1,000 µIU/mL): 5% Non-cross-reactivity
Predicate Device(s)
K 041946
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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)
The Assigned 510(k) number is K071030
JUN 2 9 2007
Date of Summary: June 26, 2007
Common Name: hCG (Human Chorionic Gonadotropin) Pregnancy 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
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- Panel: Clinical Chemistry 75
Name of Submitter:
Applied DNA Technologies Inc. 6310 Nancy Ridge Dr. Suite 106 San Diego, CA 92121, USA
Contact Person:
Feng-Yu Lee
Identification / Product Name:
Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests
Description:
The Bionexia™ hCG Pregnancy Serum/Urine Test are distributed in both Cassette and Dipstick formats. Each test reagent strip contains mouse monoclonal anti-u-hCG antibody coated membrane and a dried chemical pad containing mouse monoclonal anti-ß-hCG anybody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG.
Intended Use:
The Applied DNA Technologies Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen to help in the early determination of pregnancy.
The test kits are for health care professionals use including professionals at physician's office labs (POLs).
For a final Diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.
Predicate Kit:
ACON One Step Pregnancy Urine/Serum Test is used as predicate device for ADT's Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests to compare their performance of required studies.
510(k) number for predicate devices is:
ACON One Step Pregnancy Urine/Serum Test
K 041946
1
Performance:
The product performance characteristics of ADT's Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests were 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 ADT's Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests to be substantially equivalent to the performance characteristics of ACON's One Step Pregnancy Urine/Serum Test.
(I) Accuracy/Comparison study indicated 100% agreement in total of 95 clinical serum specimens and 94 clinical urine specimens evaluated, the study were conducted at two POL sites. (Additionally, 20 negative and 29 positive serum & urine specimens were reevaluated at a third site and similar results were obtained.)
1. Serum sample
| ACON One Step hCG Urine/Serum Test Card | ||||
|---|---|---|---|---|
| + | - | Total | ||
| BionexiaTM Panel | + | 48 | 0 | 48 |
| - | 0 | 47 | 47 | |
| Total | 48 | 47 | 95 |
2. Urine sample
| ACON One Step hCG Urine/Serum Test Card | ||||
|---|---|---|---|---|
| + | - | Total | ||
| BionexiaTM | ||||
| Panel | 47 | 0 | 47 | |
| 0 | 47 | 47 | ||
| Total | 47 | 47 | 94 |
(II) Sensitivity and Cross-reactivity
The Bionexia" hCG Pregnancy Serum/Urine Test detects serum or urinary hCG at a concentration of 20mIU/ml or greater. The test has been standardized to the WHO Fourth International Standard 75/589.
Cross-reactivity study (Specificity) evaluated at negative (0 mIU/ml) and positive (20 mIU/ml) hCG specimens showed no cross-reaction:
| Substances (level) | % Non-cross-reactivity |
|---|---|
| hCG (20 mIU/ml) | 100% |
| hLH (300 mIU/ml) | 1,500% |
| hFSH (1000 mIU/ml) | 5,000% |
| hTSH (1,000 µIU/mL) | 5% |
2
(III) Reproducibility
| Levels
| (mIU/ml) | 0 | 10 | 12.5 | 15 | 17.5 | 20 | 25 | 30 | 35 | 40 | 100 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Neg. / Pos. | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + | ||
| Lot 1 | 25 | 0 | 25 | 0 | 20 | 5 | 11 | 14 | 2 | 23 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | ||
| Lot 2 | 25 | 0 | 25 | 0 | 22 | 3 | 14 | 11 | 4 | 21 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | ||
| Lot 3 | 25 | 0 | 25 | 0 | 21 | 4 | 12 | 13 | 2 | 23 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | ||
| Lot 4 | 25 | 0 | 25 | 0 | 23 | 2 | 11 | 14 | 1 | 24 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | ||
| Total No. | 100 | 0 | 100 | 0 | 86 | 14 | 48 | 52 | 9 | 91 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | ||
| Percent. % | 100 | 0 | 100 | 0 | 86 | 14 | 48 | 52 | 9 | 91 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 |
Table 1: Serum controls
Table 2: Urine controls
| Levels
| (mIU/ml) | 0 | 10 | 12.5 | 15 | 17.5 | 20 | 25 | 30 | 35 | 40 | 100 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Neg. / Pos. | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + | ||
| Lot 1 | 25 | 0 | 25 | 0 | 23 | 2 | 11 | 14 | 1 | 24 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | ||
| Lot 2 | 25 | 0 | 25 | 0 | 19 | 6 | 12 | 13 | 1 | 24 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | ||
| Lot 3 | 25 | 0 | 25 | 0 | 21 | 4 | 14 | 11 | 3 | 22 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | ||
| Lot 4 | 25 | 0 | 25 | 0 | 24 | 1 | 9 | 16 | 2 | 23 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | ||
| Total No. | 100 | 0 | 100 | 0 | 87 | 13 | 46 | 54 | 7 | 93 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | ||
| Percent. % | 100 | 0 | 100 | 0 | 87 | 13 | 46 | 54 | 7 | 93 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 |
Conclusion:
Results of Accuracy, POL site study demonstrate the substantial equivalency between ADT's Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests and the ACON One Step Pregnancy Urine/Serum Test panel. It is also demonstrated that ADT's Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests are safe and effective in detecting human chorionic gonadotropin (hCG) in serum or urine sample to aid in the early determination of pregnancy.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, rendered in black. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Re:
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Applied DNA Technologies, Inc. c/o Feng-Yu Lee Vice President of Operation 26251 Verona Place Mission Viejo, CA 92692
JUN 2 9 2007
K071030 Trade/Device Name: Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) test system. Regulatory Class: Class II Product Code: JHI Dated: March 25, 2007 Received: April 11, 2007
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Séan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K071030
Device Name: ADT's Bionexia" hCG Pregnancy Serum/Urine Cassette and Dipstick Tests
Indications For Use:
The Applied DNA Technologies Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen at 20 mIU/mL and above to help in the early determination of pregnancy.
The test kits are for health care professionals use including professionals at physician's office labs (POLs).
For a final Diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.
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)
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K07/030