ACON COMBO PREGNANCY by ACON LABORATORIES, INC.

The test utilizes a Combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by adding specimen to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line in the Specimen Area of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line in the Control Area will always appear regardless of the presence or absence of hCG.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Acon™ Combo Pregnancy device, based on the provided "Summary of Safety & Effectiveness":

Acceptance Criteria and Device Performance

The acceptance criteria for the Acon™ Combo Pregnancy device are implicitly defined by its claimed performance characteristics and its comparison to a "commercially available serum/urine membrane test." The study aims to demonstrate 100% concordance with this predicate device.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Qualitative Agreement	100% concordance with a commercially available serum/urine membrane test for both positive and negative results in urine.	100% concordance (71 positive, 88 negative for both Acon™ Combo and comparator)
Qualitative Agreement	100% concordance with a commercially available serum/urine membrane test for both positive and negative results in serum.	100% concordance (21 positive, 51 negative for both Acon™ Combo and comparator)
Inconclusive Results	Comparable rate of inconclusive results to the predicate device.	1 inconclusive result for both Acon™ Combo and comparator in serum. (No inconclusive results reported for urine)
Sensitivity (Detection Limit)	Detects hCG concentrations of 25 mIU/ml and greater.	Device detects hCG concentrations of 25 mIU/ml and greater.
Standardization	Standardized to the World Health Organization Third International Standard.	Device has been standardized to the World Health Organization Third International Standard.
Cross-Reactivity	No cross-reactivity with hLH (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µIU/ml).	No cross-reactivity observed with the specified concentrations of hLH, hFSH, and hTSH in negative and positive serum and urine specimens.

Study Information

Sample sizes used for the test set and the data provenance:
- Urine: 159 specimens
- Serum: 73 specimens
- Data Provenance: The document does not explicitly state the country of origin. It does not specify if the data was retrospective or prospective, but the phrasing "A multi-center clinical evaluation was conducted" suggests a prospective collection for this specific evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies that the "commercially available serum/urine membrane test" served as the reference standard for ground truth. It does not mention human experts establishing ground truth for the individual test samples. The "ground truth" is effectively derived from the results of the already-marketed comparative test.
Adjudication method for the test set:
- No adjudication method is described for discrepancies between the Acon™ Combo Pregnancy test and the comparator device, as 100% concordance was reported. If there were discrepancies, the document implies the comparator device's result would be the reference.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This study compares the performance of a diagnostic device against another diagnostic device, not human readers with and without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The Acon™ Combo Pregnancy is a rapid qualitative identification test (a lateral flow immunoassay), not an algorithm or AI. Its performance, as described, is inherently standalone for detecting hCG. There is no human-in-the-loop component in its primary function of generating a result from a specimen.
The type of ground truth used:
- The ground truth relies on the results obtained from a "commercially available serum/urine membrane test." For the sensitivity and cross-reactivity studies, the ground truth would be based on known concentrations of hCG and other hormones.
The sample size for the training set:
- The document describes a clinical evaluation for validation/testing, but it does not mention a separate training set. This is typical for a traditional immunoassay device, which doesn't use machine learning algorithms that require explicit training datasets.
How the ground truth for the training set was established:
- As there's no mention of a training set for a machine learning algorithm, this question is not applicable. For the device itself, the "ground truth" for its development would have been established during its R&D phase using known concentrations of hCG and other substances, likely following validated laboratory methods and standards like the WHO Third International Standard.

Summary

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"Summary of Safety & Effectiveness"

Acon™ Combo Pregnancy is intended for the rapid qualitative identification of hCG (human Chorionic Gonadotropin) in serum or urine to aid in the early determination of pregnancy. The test utilizes a Combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by adding specimen to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line in the Specimen Area of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line in the Control Area will always appear regardless of the presence or absence of hCG.

A multi-center clinical evaluation was conducted comparing the results obtained using Acon™ Combo Pregnancy and another commercially available serum/urine membrane test. The study included 159 urine and 73 serum specimens tested with both assays. The following results were found:

	PositiveUrine Results	NegativeUrine Results
Acon™ Combo	71	88
CommerciallyAvailable Test	71	88
	PositiveSerum Results	NegativeSerum Results	InconclusiveSerum Results
Acon™ Combo	21	51	1
CommerciallyAvailable Test	21	51	1

Acon™ Combo Pregnancy showed a 100% concordance with the other commercially available test.

Acon™ Combo Pregnancy detects hCG concentrations of 25 mIU/ml and greater. The test has been standardized to the World Health Organization Third International Standard. The addition of hI.H (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µIU/ml) to negative and positive serum and urine specimens showed no cross-reactivity.

Tian Lin

9-10-1999

Date

Jixun Lin. M.D., Ph.D. Acon Laboratories, Inc. 11175 Flintkote Avenue, Suite F San Diego, CA 92121 USA

K99.3065

Prema ket Notification 510(k) Number

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the flow of health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is in black and white.

OCT 8 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jixun Lin, M.D., Ph.D. President Acon Laboratories, Inc. 11175 Flintkote Avenue Suite F San Diego, California 92121

Re: K993065

· Trade Name: Acon™ Combo Pregnancy Regulatory Class: II Product Code: JHI Dated: September 9, 1999 Received: September 13, 1999

Dear Dr. Lin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

510(k) Number: K993065

Device Name: Acon™ Combo Pregnancy

"Indications For Use" -

Jean Cooper

(Division Sign-Off) Division of Clinical Laboratory L evices 1 993065 510(k) Number _

(Please do not write below this point)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

Over-The-Counter Use

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.