K Number

Device Name

ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005

Manufacturer

UNOTECH DIAGNOSTICS, INC.

Date Cleared

2003-11-17

(54 days)

Product Code

JHI

Regulation Number

862.1155

Intended Use

The intended use of the Unotech Accutest hCG-Combo is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum for the early detection of pregnancy. The intended use of the Unotech Accustrip hCG-Combo is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum for the early detection of pregnancy.

Device Description

Not Found

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a qualitative immunoassay for pregnancy detection and does not mention any AI or ML components.

Therapeutic

No.
This device is designed for the diagnosis of pregnancy by detecting hCG, which is a diagnostic function, not a therapeutic one.

Diagnostic

Yes

The device's intended use is for the "qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum for the early detection of pregnancy," which directly indicates its role in diagnosing pregnancy.

SaMD (Software as a Medical Device)

The summary describes a device for the qualitative determination of hCG in urine or serum, which is typically performed using physical test strips or kits, not software alone. The performance studies involve testing physical specimens.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum. This involves testing biological samples in vitro (outside the body).
Purpose: The purpose is the "early detection of pregnancy," which is a diagnostic purpose.
Sample Type: The device analyzes human urine or serum, which are biological specimens.
Care Setting: The intended user is clinical laboratories, which are settings where in vitro diagnostic tests are performed.

All of these characteristics align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The intended use of the Unotech AccuTest™ hCG-Combo and AccuStrip™ hCG-Como is for the early detection of pregnancy by the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum.
The intended use of the Unotech Accutest hCG-Combo is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum for the early detection of pregnancy.
The intended use of the Unotech Accustrip hCG-Combo is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum for the early detection of pregnancy.

Product codes

JHI

Device Description

Not Found

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

Our intent is to market these products to clinical laboratories in the U.S.A. as well as in the foreign countries.

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)

We conducted a comparison study with Unotech's AccuTest™ hCG-Combo, AccuStrip™ hCG-Combo and Quidel's QuickVue hCG Combo Test. A total of 181 specimens (94 urine specimens and 87 serum specimens) from patients seeking confirmation of pregnancy were tested simultaneously with AccuTest™ hCG-Combo, AccuStrip™ hCG-Combo and QuickVue hCG Combo tests. Test results show that both Unotech's AccuTest™ hCG-Combo and AccuStrin™ hCG-Combo have 100% agreement with the QuickVue hCG Combo Test.
The following experiments were carried out to evaluate the sensitivity of AccuTest™ hCG-Combo, and AccuStrip™ hCG-Combo at low end and high end levels of hCG. Pooled negative urine and serum specimens were spiked with hCG to the concentrations of 0, 25, 50, 10^4, 5x10^5 and 10^6 mIU/mL and tested with AccuTest™ hCG-Combo and AccuStrip™ hCG-Combo. A total of 60 urine samples and 60 serum samples were blind labeled and tested with the AccuTest™ hCC-Combo and AccuStrip™ hCG-Combo. Test results obtained from these experiments are the same using AccuTest™ hCG-Combo or AccuStrip™ hCG-Combo Tests with serum or urine specimens. The results demonstrate that the Unotech AccuTest™ hCG-Combo and AccuStrip™ hCG-Combo can detect hCG in urine or serum at levels as low as 25 mIU/mL and as high as 1,000,000 mIU/mL.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

The results demonstrate that the Unotech AccuTest™ hCG-Combo and AccuStrip™ hCG-Combo can detect hCG in urine or serum at levels as low as 25 mIU/mL and as high as 1,000,000 mIU/mL.

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.

Not Found

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

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.

Summary

NOV 17 2003

032987

510(k) Notification Unotech Diagnostics Inc. AccuTest™ hCG-Combo AccuStrip™hCG-Combo September 22, 2003

510(k) Summary of Safety and Substantial Equivalence Discussio

Trade or Proprietary Name:	AccuTest TM hCG-Combo AccuStrip TM hCG-Combo
Common or Usual Name:	Human Chorionic Gonadotropin Test System
Product Classification No.:	21 CFR §862.1155, Class II
Manufacturer:	Unotech Diagnostics Inc. 2235 Polvorosa Avenue, Suite 220 San Leandro, CA 94577
Contact Person:	Ken Wu, Ph.D. President Phone: (510) 352-3070

Comparison of AccuTest™ hCG-Combo and AccuStrip™ hCG-Combo with the Table 1A: Quidel QuickVue hCG Combo Test Using Urine Specimens

| | Unotech
AccuTest™ hCG-Combo | Unotech
AccuStrip™ hCG-Combo | Quidel
QuickVue hCG Combo |
|----------|--------------------------------|---------------------------------|------------------------------|
| Positive | 48 | 48 | 48 |
| Negative | 46 | 46 | 46 |

Comparison of AccuTest™ hCG-Combo and AccuStrip™ hCG-Combo with the Table 1B: Ouidel OuickVue hCG Combo Test Using Serum Specimens

The following experiments were carried out to evaluate the sensitivity of AccuTest™ hCG-Combo, and AccuStrip™ hCG-Combo at low end and high end levels of hCG. Pooled negative urine and serum specimens were spiked with hCG to the concentrations of 0, 25, 50, 104, 5×10° and 10° mIU/mL and tested with AccuTest™ hCG-Combo and AccuStrip™ hCG-Combo. A total of 60 urine samples and 60 serum samples were blind labeled and tested with the AccuTest™ hCC-Combo and AccuStrip™ hCG-Combo. Test results obtained from these experiments are the same using AccuTest™ hCG-Combo or AccuStrip™ hCG-Combo Tests with serum or urine specimens. The results are presented in Table 2.

Table 2:	Sensitivity Test Results
----------	--------------------------

hCG (mIU/mL)	0	25	50	$10^4$	$5\times10^5$	$10^6$
# of samples	10	10	10	10	10	10
Positive	0	10	10	10	10	10
Negative	10	0	0	0	0	0

The results demonstrate that the Unotech AccuTest™ hCG-Combo and AccuStrip™ hCG-Combo can detect hCG in urine or serum at levels as low as 25 mIU/mL and as high as 1,000,000 mIU/mL.

These results establish that the Unotech AccuTest™ hCG-Combo and AccuStrip™ hCG-Combo are substantially equivalent to the Quidel QuickVue hCG Combo Test.

The intended use of the Unotech AccuTest™ hCG-Combo and AccuStrip™ hCG-Como is for the early detection of pregnancy by the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum. Our intent is to market these products to clinical laboratories in the U.S.A. as well as in the foreign countries.

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.

NOV 17 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ken Wu. Ph.D. President Unotech Diagnostics Inc. 2235 Polvorosa Avenue - Suite 220 San Leandro, CA 94577

K032987 Re:

Trade/Device Name: Unotech Accutest™ hCG-Combo and Accustrip™ hCG-Combo Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (hCG) test system Regulatory Class: Class II Product Code: JHI Dated: September 22, 2003 Received: September 26, 2003

Dear Dr. Wu:

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).

Page 2 –

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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

Recod 10-27-03

Page 1 of 2

510(k) Number (if know): N/A_

Device Name: Accutest hCG-Combo

Indications For Use:

The intended use of the Unotech Accutest hCG-Combo is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum for the early detection of pregnancy.

Carol Benson for Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032987

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGES IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Recyd 10-21-03

Page 2_of_2

510(k) Number (if know): N/A

Device Name: Accustrip hCG-Combo

Indications For Use:

The intended use of the Unotech Accustrip hCG-Combo is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum for the early detection of pregnancy.

Carol C. Benson & Jean Cooper, OVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032987

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGES IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use J (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)