(38 days)
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No
The device description and performance studies describe a standard lateral flow immunoassay, with no mention of AI or ML technologies.
No.
The device is a diagnostic tool for pregnancy detection, not a therapeutic device designed for treatment or therapy.
Yes
The device is described as an "immunological test for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy," which directly indicates its use for diagnosing pregnancy.
No
The device description clearly states it is a rapid lateral flow colloidal gold immunological test, which is a physical test strip, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy." This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Device Description: The description reinforces that it's a "rapid lateral flow colloidal gold immunological tests for the qualitative determination of human chorionic gonadotropin (hCG) in urine." This describes the technology used to perform the in vitro diagnostic test.
- Intended User / Care Setting: The intended users are "physician's office laboratories, clinics and hospital and reference laboratories," which are settings where in vitro diagnostic testing is typically performed.
- Performance Studies: The description of performance studies involves testing urine specimens to evaluate the device's ability to detect hCG, which is a core aspect of validating an in vitro diagnostic test.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JHI
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
physician's office laboratories, clinics and hospital and reference laboratories.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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™. A total of 131 specimens were tested. Test results showed 100% agreement with the Abbott Test Pack Plus™.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 25mlU/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.
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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.
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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).
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§ 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
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 STEP
ACCUNATE™ONE STEP CASSETTE | | | |
|------------------------|--------------------------------------------------------------------------|--|--|--|
| Common name: | Pregnancy test for urine | | | |
| Classification: | 21CFR862.1155, Class II | | | |
| Classification number: | 75DHAJHI | | | |
| Establishment: | Cenogenics Corporation
100 Route 520
Morganville, New Jersey 07751 | | | |
| Contact: | Nitza Katz | | | |
Vice President
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.
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 STEP
CASSETTE | ABBOTT TEST PACK
PLUSTM |
|------------------|--------------------|--------------------------------|----------------------------|
| NO. OF POSITIVES | 63 | 63 | 63 |
| NO. OF NEGATIVES | 68 | 68 | 68 |
1
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.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image. The text is in all capital letters and is evenly spaced around the circle.
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
: -
4
CENOGENICS CORPORATION
Page of
510(k) Number:_ K992397
Device Name: __ ACCUNATE™-ONE STEP
ACCUNATE™-ONE STEP CASSETTE
Indications For Use:
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.
The product will be marketed to physician's office laboratories, clinics and hospital and reference laboratories.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K 992397
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)