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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Bionexia™ hCG Pregnancy Cassette and Dipstick Tests, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Target / Criterion	Reported Device Performance
Accuracy / Comparison Study	Substantial equivalence to predicate device (ACON One Step Pregnancy Urine Test)	100% agreement with the predicate device (ACON One Step hCG Test Card) in 95 clinical urine specimens. (48 positive, 47 negative). Re-evaluation of 20 negative and 29 positive specimens at a third site also showed similar results.
Sensitivity	Detection of ß-Human Chorionic Gonadotropin at a concentration of 20 mIU/ml or greater in urine specimen. Standardized to WHO Fourth International Standard 75/589.	The Bionexia™ hCG Pregnancy Test detects ß-Human Chorionic Gonadotropin at a concentration of 20 mIU/ml or greater. The provided table shows (at 20 mIU/ml): 100% positive results across 4 lots (100 out of 100 specimens detected as positive at 20 mIU/ml). For levels below 20 mIU/ml, there's a graded response, suggesting the 20 mIU/ml threshold is met (e.g., at 17.5 mIU/ml, 92% positive; at 15 mIU/ml, 56% positive).
Specificity (Cross-reactivity)	No cross-reaction with interfering substances at specified levels.	hCG (20 mIU/ml): 100% Non-cross-reactivity (This seems to imply 100% specific for hCG at 20mIU/ml, or perhaps the table header is misleading and it refers to 100% detection of hCG, but the context of "cross-reactivity" suggests it means no cross-reactivity with other substances at the hCG levels tested for specificity. Given the other rows, it's more likely this indicates it correctly identifies hCG and isn't cross-reacting with other substances as if it were hCG.).hLH (300 mIU/ml): >500% (likely 0% cross-reactivity, implies at 300mIU/ml hLH, the device gives a negative result).hFSH (1000 mIU/ml): >5.000% (likely 0% cross-reactivity).hTSH (1.000 ulUmL): >5% (likely 0% cross-reactivity).(Interpretation of "% Non-cross-reactivity" and the values 500% and 5.000% is ambiguous; it most likely means no detectable cross-reactivity at these high concentrations, where a negative result is desired.)
Reproducibility	Demonstrated consistency across multiple tests/lots.	Results demonstrated substantial equivalency with the predicate device. (Specific quantitative results not provided in the summary, but implied through this statement).
Safety and Effectiveness	Demonstrated as safe and effective.	Demonstrated as safe and effective in detecting hCG in urine.

2. Sample Size Used for the Test Set and Data Provenance

Accuracy/Comparison Study (Test Set):
- Sample Size: 95 clinical urine specimens (48 positive, 47 negative). An additional 49 specimens (20 negative, 29 positive) were re-evaluated at a third site.
- Data Provenance: Clinical specimen correlation study, including POLs (Physician's Office Labs) site study. This indicates the data is prospective from clinical settings. The country of origin is not explicitly stated in the provided text, but the submitter's address is in San Diego, CA, USA, implying the study was likely conducted within the USA.
Sensitivity/Cross-reactivity Study (Test Set):
- Sample Size: For sensitivity, 100 specimens per level per lot, across 4 lots (totaling 400 specimens tested across the concentration curve). For cross-reactivity, the specific number of spiked samples is not given, but results are provided for various substances at specified levels.
- Data Provenance: This appears to be a laboratory-based study using spiked controls, rather than clinical specimens for this specific component.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number of experts or their specific qualifications for establishing ground truth.
For the accuracy/comparison study, the comparison is made against a "predicate device" (ACON One Step Pregnancy Urine Test). The "ground truth" for these clinical samples is implicitly the result obtained from the predicate device, as the study aims to show agreement with it.
For the sensitivity and cross-reactivity studies, the ground truth is established by the known concentration of spiked hCG or other substances.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Given that the comparison study is against a predicate device, it's likely that the predicate device's result was considered the reference, and discrepancies would have been examined, but the process is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a rapid diagnostic test (lateral flow immunoassay) for visual reading, not an AI-powered diagnostic imaging device that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance was done. This device is intended to be read visually by healthcare professionals, meaning its performance is inherently a "standalone" interpretation of the test result without an AI algorithm. The performance evaluation directly assesses the device's ability to produce accurate results.

7. The Type of Ground Truth Used

Accuracy/Comparison Study: The ground truth for clinical specimens was derived from the results of the predicate device (ACON One Step Pregnancy Urine Test).
Sensitivity and Specificity (Cross-reactivity) Studies: The ground truth was based on known concentrations of spiked analytes (hCG) and known concentrations of potential interfering substances. This is a form of laboratory-controlled ground truth.

8. The Sample Size for the Training Set

The provided document does not mention a "training set" in the context of machine learning or AI. This is a point-of-care diagnostic device, not an AI/ML algorithm. Therefore, there is no training set in that sense. The studies described are performance validation studies.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI/ML algorithm, this question is not applicable to the Bionexia™ hCG Pregnancy Test.

Summary

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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:

1. Regulation section: 21 CFR part 862.1155, Human Chorionic Gonadotropin test system
1. Classification: Class II
1. Product Code: JHI, radioimmunoassay, human chorionic gonadotropin
1. 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:

Intended Use:

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

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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
BionexiaTMPanel	+	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.

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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

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Indications for Use

510(k) Number (if known): K070921

Device Name: ADT's Bionexia™ hCG Pregnancy Cassette and Dipstick Tests

Indications For Use:

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

Regulation Number and Section

§ 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.