ACCUNATE™-ONE STEP and ACCUNATE™-ONE STEP CASSETTE are rapid lateral flow colloldal gold immunological tests for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.

Device Description

ACCUNATE™-ONE STEP and ACCUANTE™-ONE STEP CASSETTE are rapid lateral flow colloidal gold immunological tests for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.

AI/ML Overview

The acceptance criteria and study proving the device meets them are as follows:

1. Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
HCG Detection: Qualitative determination of hCG in urine for early pregnancy detection.	ACCUNATE™-ONE STEP and ACCUNATE™-ONE STEP CASSETTE are rapid lateral flow colloidal gold immunological tests for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.
Agreement with Predicate Device: Test results should show high agreement with a legally marketed predicate device (Abbott Test Pack Plus™).	100% agreement with the Abbott Test Pack Plus™ was observed in comparison studies. Both the predicate and the investigational devices showed 63 positives and 68 negatives for a total of 131 specimens.
Sensitivity: The device should be able to detect hCG at clinically relevant concentrations.	Sensitivity was demonstrated to be 25 mIU/ml. At 25 mIU/ml, 50 mIU/ml, and 100 mIU/ml, all 20 tested samples yielded positive results. At 0 IU/ml and 5 mIU/ml, all 20 tested samples yielded negative results.

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

Comparison Study:
- Sample Size: 131 urine specimens.
- Data Provenance: Not explicitly stated, but implies prospective collection as specimens were "from patients seeking confirmation of pregnancy" and tested "simultaneously" at three clinic sites. The country of origin is not specified, but the applicant and testing sites are located in the US.
Sensitivity Study:
- Sample Size: 20 urine specimens from normal males and non-pregnant females for each hCG concentration (0 IU/ml, 5 mIU/ml, 25 mIU/ml, 50 mIU/ml, and 100 mIU/ml), totaling 100 tests.
- Data Provenance: Retrospective, as urine specimens were "spiked with hCG". The country of origin is not specified.

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

Comparison Study: The ground truth for the comparison study appears to be established by the results of the predicate device, the Abbott Test Pack Plus™. No information is provided on the number or qualifications of experts involved in determining the "true" positive or negative status of the samples beyond the predicate device's results.
Sensitivity Study: For the sensitivity study, the ground truth was established by the known concentration of spiked hCG. No human experts were involved in establishing this ground truth.

4. Adjudication Method for the Test Set:

Comparison Study: Not explicitly stated. The document implies a direct comparison of results between the investigational devices and the predicate device. With 100% agreement, there was no need for adjudication of discordant results.
Sensitivity Study: Not applicable, as the ground truth was based on known hCG concentrations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This device is a qualitative in vitro diagnostic test, not an imaging or diagnostic AI tool requiring human-in-the-loop performance evaluation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, the studies presented are standalone evaluations of the device's performance. Both the comparison study and the sensitivity study assessed the ACCUNATE™-ONE STEP devices' ability to detect hCG in urine without human interpretation influencing the final result beyond observing the test line.

7. Type of Ground Truth Used:

Comparison Study: The ground truth was based on the results of a legally marketed predicate device, the Abbott Test Pack Plus™.
Sensitivity Study: The ground truth was based on artificially created samples with known concentrations of hCG (spiked urine specimens).

8. Sample Size for the Training Set:

This information is not provided. The 510(k) summary describes performance studies, not the development or training of an algorithm. Given the simplicity of the test type (lateral flow immunoassay), it is unlikely there was a "training set" in the sense of a machine learning algorithm. The "training" would be more akin to internal R&D and optimization of reagents and manufacturing processes.

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

Not applicable, as a training set in the context of an algorithm or machine learning is not mentioned or relevant for this type of device submission.

Summary

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K992397

ogenics Corporatio

Telephone (732) 536-6457 / (800) 747-9457 / Fax (732) 972-8527 100 Route 520, Drawer 308, Morganville, New Jersey 07751

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Proprietary name:	ACCUNATE™-ONE STEPACCUNATE™ONE STEP CASSETTE
Common name:	Pregnancy test for urine
Classification:	21CFR862.1155, Class II
Classification number:	75DHAJHI
Establishment:	Cenogenics Corporation100 Route 520Morganville, New Jersey 07751
Contact:	Nitza Katz

Vice President

Comparison studies were conducted at three clinic sites. Urine specimens from patients seeking confirmation of pregnancy were tested simultaneously with ACCUNATE™-ONE STEP and ACCUANTE™-ONE STEP CASSETTE and the Abbott Test Pack Plus™. The Test Pack Plus™ is a similar colloidal gold test for the qualitative determination of hCG in urine for the early detection of pregnancy. A total of 131 specimens were tested. Test results showed 100% agreement with the Abbott Test Pack Plus™. TABLE 1 demonstrates distribution of positive and negative specimens.

TABLE 1: Comparison of ACCUANTE™-ONE STEP and ACCUNATE™-ONE STEP CASSETTE with the Abbott Test Pack Plus™

	ACCUNATE™-ONE STEP	ACCUNATE™-ONE STEPCASSETTE	ABBOTT TEST PACKPLUSTM
NO. OF POSITIVES	63	63	63
NO. OF NEGATIVES	68	68	68

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Twenty urine specimens from normal males and non pregnant females were spiked with hCG at concentrations of 5, 25, 50 and 100mlU/ml. Each urine specimen was tested at the hCG concentrations stated and at 01U/ml with both the ACCUNATE™ ONE STEP and ACCUNATE™-ONE STEP CASSETTE. Testing data demonstrates the sensitivity to be 25mlU/ml. Test results are shown in TABLE 2.

TABLE 2: SENSITIVITY TEST RESULTS

	hCG CONCENTRATION
	0IU/ml	5mlU/ml	25mlU/ml	50mlU/ml	100mlU/ml
NO. OF SAMPLES TESTED	20	20	20	20	20
POSITIVE RESULTS	0	0	20	20	20
NEGATIVE RESULTS	20	20	0	0	0

The ACCUANTE™-ONE STEP and the ACCUNATE™-ONE STEP CASSETTE are substantially equivalent to the ABBOTT TEST PACK PLUS™ as demonstrated by the The devices are equivalent in test principle, sensitivity and above testing data. performance.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 26 lang

Ms. Nitza Katz Vice President Cenogenics Corporation 100 Route 520 Drawer 308 Morganville, New Jersey 07751

Re: K992397

Trade Name: Accunate™-ONE STEP Accunate™-ONE STEP CASSETTE Regulatory Class: II Product Code: JHI Dated: July 15, 1999 Received: July 19, 1999

Dear Ms. Katz:

ーで

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 (QS) 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

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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/cdrlv/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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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CENOGENICS CORPORATION

Page of

510(k) Number:_ K992397

Device Name: __ ACCUNATE™-ONE STEP

ACCUNATE™-ONE STEP CASSETTE

Indications For Use:

The product will be marketed to physician's office laboratories, clinics and hospital and reference laboratories.

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Division of Clinical Laboratory Devices
510(k) Number. K 992397

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use √
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.