(88 days)
K 993203
Not Found
No
The device description and performance studies focus on traditional immunoassay technology and do not mention any AI or ML components.
No.
The device is for diagnostic purposes (detection of hCG to help in early determination of pregnancy), not for treating or preventing a disease or condition.
Yes
This device is a rapid immunoassay for the detection of hCG in urine, which is used to help in the early determination of pregnancy. This is a diagnostic function, even though a final diagnosis of pregnancy requires a more specific alternative clinical method.
No
The device description clearly states it is a rapid chromatographic immunoassay with reagent strips containing antibodies and colloidal gold conjugate, indicating it is a physical test kit, not software.
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 urine to help in the early determination of pregnancy." This involves testing a biological sample (urine) in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details the components of the test, which are reagents designed to interact with substances in the urine sample.
- Performance Studies: The document describes studies evaluating the device's performance using clinical urine specimens and spiked controls, which is typical for IVD validation.
- Predicate Device: The mention of a predicate device (ACON One Step Pregnancy Urine Test) which is also an IVD, further supports its classification as an IVD.
The core function of the device is to analyze a biological sample (urine) in vitro to provide information about a physiological state (pregnancy), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Applied DNA Technologies Bionexia™ hCG Pregnancy Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in urine 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 (comma separated list FDA assigned to the subject device)
JHI
Device Description
The Bionexia™ hCG Pregnancy Test will be distributed in both Cassette and Dipstick formats. Each test reagent strip contains mouse monoclonal anti-a-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
The test kits are for 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 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 Cassette and Dipstick Tests to be substantially equivalent to the performance characteristics of ACON's One Step Pregnancy Urine Test.
(I) Accuracy/Comparison study indicated 100% agreement in total of 95 clinical urine specimens evaluated, the study was conducted at two POL sites. (Additionally, 20 negative and 29 positive urine specimens were reevaluated at a third site and similar results were obtained.)
(II) Sensitivity and Cross-reactivity
The Bionexia " hCG Pregnancy Test detects ß- Human Chorionic Gonadotropin at a concentration of 20mlU/ml or greater in urine specimen. 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:
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy/Comparison study indicated 100% agreement in total of 95 clinical urine specimens evaluated.
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.
K 993203
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)
The Assigned 510(k) number is K070921
Date of Summary: June 26, 2007
JUN 2 9 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 Cassette and Dipstick Tests
Description:
The Bionexia™ hCG Pregnancy Test will be distributed in both Cassette and Dipstick formats. Each test reagent strip contains mouse monoclonal anti-a-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 Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in urine 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 Test is used as predicate device for ADT's Bionexia™ hCG Pregnancy Cassette and Dipstick Tests to compare their performance of required studies.
510(k) numbers for predicate devices is: ACON One Step Pregnancy Urine Test
K 993203
1
Performance:
The product performance characteristics of ADT's Bionexia™ hCG Pregnancy 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 Cassette and Dipstick Tests to be substantially equivalent to the performance characteristics of ACON's One Step Pregnancy Urine Test.
(1) Accuracy/Comparison study indicated 100% agreement in total of 95 clinical urine specimens evaluated, the study was conducted at two POL sites. (Additionally, 20 negative and 29 positive urine specimens were reevaluated at a third site and similar results were obtained.)
| ACON One Step hCG Test Card | ||||
|---|---|---|---|---|
| + | - | Total | ||
| BionexiaTM | ||||
| Panel | + | 48 | 0 | 47 |
| - | 0 | 47 | 47 | |
| Total | 48 | 47 | 95 |
(II) Sensitivity and Cross-reactivity
The Bionexia " hCG Pregnancy Test detects ß- Human Chorionic Gonadotropin at a concentration of 20mlU/ml or greater in urine specimen. 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) | .500% | ||||||
| hFSH (1000 mIU/ml) | 5.000% | ||||||
| hTSH (1.000 ulUmL) | 5% |
| 0 | 10 | 12.5 | 15 | 17.5 | 20 | 25 | 30 | 35 | 40 | 100 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Levels | ||||||||||||||||||||||
| (mIU/ml) | ||||||||||||||||||||||
| Neg. / Pos. | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + | - | + |
| Lot 1 | 25 | 0 | 25 | 0 | 23 | 2 | 11 | 14 | 2 | 23 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 |
| Lot 2 | 25 | 0 | 25 | 0 | 19 | 6 | 10 | 15 | 1 | 24 | 0 | 25 | 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 | 0 | 25 |
| Lot 4 | 25 | 0 | 25 | 0 | 24 | 1 | 9 | 16 | 2 | 23 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 | 0 | 25 |
| Total No. | 100 | 0 | 100 | 0 | 87 | 13 | 44 | 56 | 8 | 92 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 |
| Percent. % | 100 | 0 | 100 | 0 | 87 | 13 | 44 | 56 | 8 | 92 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 100 |
(H) Reproducibility
Conclusion:
Results of Accuracy, Reproducibility, and POL site studies demonstrated the substantial equivalency between ADT's Bionexia™ hCG Pregnancy Cassette and Dipstick Tests and the ACON One Step Pregnancy Urine Test panel. It is also demonstrated that ADT's Bionexia™ hCG Pregnancy Cassette and Dipstick Tests are safe and effective in detecting human chorionic gonadotropin (hCG) in urine to aid in the early determination of pregnancy.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 9 2007
Applied DNA Technologies, Inc. c/o Feng-Yu Lee Vice President of Operation 26251 Verona Place Mission Viejo, CA 92692
Re: K070921
Trade Name: Bionexia hCG Pregnancy 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: May 31, 2007 Received: June 01, 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 legally marketed predicate device results in a classification for your device and thus, perroits 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 yours,
Jean M. Cooper, M.S., D.V.M.
Jean 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
4
Indications for Use
510(k) Number (if known): K070921
Device Name: ADT's Bionexia™ hCG Pregnancy Cassette and Dipstick Tests
Indications For Use:
The Applied DNA Technologies Bionexia™ hCG Pregnancy Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in urine at 20 mlU/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)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
C.C.
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
070921