(104 days)
Not Found
No
The device is a urine collection and preservation system, and the description focuses on chemical preservation and performance studies related to preserving nucleic acids for existing diagnostic assays. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is for the collection, preservation, and transport of urine specimens for diagnostic testing, not for treating a disease or condition.
No
The device is described as a "Urine Collection, Preservation and Transport System" and its intended use is for the "collection, preservation, and transportation of urine specimens" for testing with specific assays. It does not perform diagnostic functions itself but rather prepares samples for diagnostic tests.
No
The device description explicitly states it is comprised of a urine collection cup containing a nucleic acid chemical preservative and inert indicator beads, indicating it is a physical device with chemical components, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "collection, preservation, and transportation of urine specimens... for testing with the Abbott LCx® Neisseria qonorrhoeae and Chlamydia trachomatis assays." These assays are diagnostic tests performed in vitro (outside the body) on biological specimens (urine) to detect specific analytes (gonococcal and chlamydial nucleic acid).
- Device Description: The device contains a "nucleic acid chemical preservative" and is designed to preserve urine specimens for "LCx® gonococcal or chlamydial testing." This further reinforces its role in preparing a specimen for an in vitro diagnostic test.
- Performance Studies: The performance studies describe testing the effectiveness of the device in preserving specimens for "LCx® testing," which is an in vitro diagnostic method.
- Predicate Devices: The predicate devices listed are the Abbott LCx® Neisseria gonorrhoeae and Chlamydia trachomatis assays, which are themselves IVD tests. This indicates that the Sierra device is intended to be used in conjunction with these IVD tests.
The device's function is to prepare a biological specimen (urine) for subsequent in vitro diagnostic testing. This directly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sierra Diagnostics L.L.C. Urine Collection, Preservation and Transport System is intended for use in the collection, preservation, and transportation of urine specimens at temperatures not exceeding 60°C for testing with the Abbott LCx® Neisseria gonorrhoeae and Chlamydia trachomatis assays.
The Sierra Diagnostics L.L.C. Urine Collection, Preservation and Transport System is indicated for use in the collection, preservation, and transportation of urine specimens at temperatures not exceeding 60°C for testing with the Abbott LCx® Neisseria gonorrhoeae and Chlamydia trachomatis assays.
Product codes (comma separated list FDA assigned to the subject device)
JTW
Device Description
The device is comprised of a urine collection cup containing of a nucleic acid chemical preservative. The device allows urine specimens for LCx® gonococcal or chlamydial testing to be preserved for up to 6 days at temperatures not to exceed 60°C. Inert indicator beads are included in the urine cup as an indicator that a preservative is present in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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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)
The effectiveness of the Sierra Urine Collection, Preservation, and Transport System was established by the comparative testing of fresh and preserved urine spiked with gonococcal and chlamydial DNA. LCx® testing of samples that were preserved through refrigeration for 24 hours were compared with results for specimens preserved with the Sierra device and tested after being held for 144 hrs. at 60°C. There was a 100% correlation between the refrigerated and preserved samples.
Effectiveness was further established by a multi-site clinical study. The results of this study demonstrated that the device effectively preserved gonococcal and chlamydial nucleic acid targets in urine specimens from symptomatic and asymptomatic males and females.
The effective preservative concentration range and effect on LCx® sensitivity was established by a study using urine specimens spiked with less than 10 cfu of 10 different gonococcal serovars. Results from this test proved that Sierra's device effectively preserved nucleic acid targets down to the LCx® level of detection with a preservative to urine ratio ranging from 1:10 to 1:15.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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§ 866.2900 Microbiological specimen collection and transport device.
(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
0
FEB 2 8 2002
510(k) Summary
I. General Information on Submitter
Name: Address:
Telephone:
Contact Person:
Date Prepared:
Fax:
Sierra Diagnostics, L.L.C. 21109 Longeway #C Sonora, CA 95370 (209) 536-0886 (209) 536-0853 Tony Baker October __ , 2001
II. General Information on Device
| Name: | Sierra Diagnostics L.L.C. Urine Collection,
Preservation and Transport System |
|----------------------|----------------------------------------------------------------------------------|
| Classification Name: | Accessory to Neisseria spp. and Chlamydia
serological reagents |
III. Predicate Device
The standard urine collection cup used to collect specimens for testing with the Abbott LCx® Neisseria qonorrhoeae and Chlamydia trachomatis assays and referenced in the package inserts for the LCx® devices (See 510/k) Nos. K935833 (Neisseria gonorrhoeae) and K934622 (Chlamydia trachomatis)).
Description of Device IV.
The device is comprised of a urine collection cup containing of a nucleic acid chemical preservative. The device allows urine specimens for LCx® gonococcal or chlamydial testing to be preserved for up to 6 days at temperatures not to exceed 60°C. Inert indicator beads are included in the urine cup as an indicator that a preservative is present in the sample.
V. Intended Use
The Sierra Diagnostics L.L.C. Urine Collection, Preservation and Transport System is intended for use in the collection, preservation, and transportation of urine specimens at temperatures not exceeding 60°C for testing with the Abbott LCx® Neisseria qonorrhoeae and Chlamydia trachomatis assays.
1
Technological Characteristics of Device Compared to Predicate Device VI.
The Sierra Urine Collection, Preservation, and Transport System and the predicate device share the same technological characteristics with the exception of the method of preservation. The predicate device employs a temperature preservation method while the Sierra device uses chemical preservation.
Summary of Performance Data VII.
The effectiveness of the Sierra Urine Collection, Preservation, and Transport System was established by the comparative testing of fresh and preserved urine spiked with gonococcal and chlamydial DNA. LCx® testing of samples that were preserved through refrigeration for 24 hours were compared with results for specimens preserved with the Sierra device and tested after being held for 144 hrs. at 60°C. There was a 100% correlation between the refrigerated and preserved samples.
Effectiveness was further established by a multi-site clinical study. The results of this study demonstrated that the device effectively preserved gonococcal and chlamydial nucleic acid targets in urine specimens from symptomatic and asymptomatic males and females.
The effective preservative concentration range and effect on LCx® sensitivity was established by a study using urine specimens spiked with less than 10 cfu of 10 different gonococcal serovars. Results from this test proved that Sierra's device effectively preserved nucleic acid targets down to the LCx® level of detection with a preservative to urine ratio ranging from 1:10 to 1:15.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 8 2002
Sierra Diagnostics, L.L.C. c/o Donald R. Stone, Esq. Kirkpatrick and Lockhart, LLP 1800 Massachusetts Avenue, NW Suite 200 Washington, DC 20036-1221
K013819 Re:
Ro13017
Trade/Device Name: Sierra Diagnostics L.L.C. Urine Collection, Preservation and Transport System Regulation Number: 21 CFR 866.2900 Regulation Name: Microbiological Specimen Collection and Transport System Regulatory Class: Class I Product Code: JTW Dated: February 11, 2002 Received: February 12, 2002
Dear Mr. Stone:
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 he found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
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 1 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, (201) 59 react the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mornation on Jour responsiver 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
4
510(k) Number:
Sierra Diagnostics L.L.C. Urine Collection, Preservation and Transport Device Name: System
Indications for Use:
The Sierra Diagnostics L.L.C. Urine Collection, Preservation and Transport System is indicated for 1 use in the collection, preservation, and transportation of urine specimens at temperatures not ase in the concession, proses with the Abbott LCx® Neisseria gonorrhoeae and Chlamydia trachomatis assays.
PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IN NEEDED
` Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √
(Per 21 CFR 801.109)
(Division Sio ver-The Counter Use Inical Laboratory L Division of C
510(k) Number_KO13