(104 days)
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.
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.
Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary:
Given the nature of the device (urine collection, preservation, and transport system) and the provided text, the acceptance criteria are not explicitly stated in numerical terms typical for diagnostic accuracy (e.g., sensitivity, specificity). Instead, the criteria relate to the effectiveness of preservation and correlation of results compared to a predicate method.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Preservation Effectiveness: The device must effectively preserve gonococcal and chlamydial nucleic acid targets in urine specimens, maintaining their integrity for subsequent LCx® testing. | Demonstrated effective preservation of gonococcal and chlamydial nucleic acid targets in urine specimens from symptomatic and asymptomatic males and females. |
| Correlation with Predicate Method: Results from specimens preserved with the Sierra device should correlate with results from specimens preserved via the predicate method (refrigeration). | 100% correlation between refrigerated samples (24 hours) and Sierra-preserved samples (144 hours at 60°C). |
| Preservative Concentration Range & Sensitivity: The device should effectively preserve nucleic acid targets down to the LCx® level of detection across a specified preservative-to-urine ratio. | 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. |
| Temperature/Time Stability: The device must preserve urine specimens for up to 6 days at temperatures not exceeding 60°C. | LCx® testing compared samples refrigerated for 24 hours with Sierra-preserved samples held for 144 hours (6 days) at 60°C. Implies successful preservation under these conditions. |
2. Sample size used for the test set and the data provenance
- Sample Size:
- Comparative Testing (Spiked Samples): Not explicitly stated how many samples were used for the gonococcal and chlamydial DNA spiking experiment.
- Multi-Site Clinical Study: Not explicitly stated.
- Preservative Concentration Study: Not explicitly stated, but mentioned "urine specimens spiked with less than 10 cfu of 10 different gonococcal serovars." This implies at least 10 specimens, likely more for various concentrations.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be prospective as they involved controlled experiments (spiking, controlled temperature/time, multi-site clinical study testing the device).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device is based on laboratory assays (LCx® testing for Neisseria gonorrhoeae and Chlamydia trachomatis nucleic acid detection), not expert consensus on images or clinical findings. The "experts" would be the laboratory technicians performing and interpreting the LCx® assays.
4. Adjudication method for the test set
Not applicable. Ground truth is established by a quantitative laboratory assay (LCx®), not by human interpretation requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a pre-analytic collection, preservation, and transport system, not an AI-assisted diagnostic tool. No human "readers" are involved in interpreting its direct output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence, the performance shown is standalone for the device's function. The device's ability to preserve nucleic acids is tested directly, and the output (presence/absence of nucleic acid via LCx®) is objective. While the downstream LCx® assay itself is a laboratory test, the performance data presented here focuses solely on the preservation capability of the Sierra device when used with that assay.
7. The type of ground truth used
The ground truth used is primarily laboratory assay results (Abbott LCx® Neisseria gonorrhoeae and Chlamydia trachomatis assays) on fresh or spiked specimens.
- For the comparative testing, the ground truth was the LCx® result of refrigerated fresh samples.
- For the spiking studies, the ground truth was the known presence/absence and concentration of spiked nucleic acid, detected by LCx®.
- For the multi-site clinical study, the ground truth would have been the LCx® results from the freshly collected specimens from symptomatic and asymptomatic individuals, against which the preserved specimens were compared.
8. The sample size for the training set
Not mentioned. This is a medical device for specimen handling, not a machine learning model, so "training set" is not a standard concept here in the sense of model development. The studies described are performance evaluation studies.
9. How the ground truth for the training set was established
Not applicable, as there's no "training set" in the context of machine learning. The studies described are for evaluating the device's performance.
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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 Chlamydiaserological 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.
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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.
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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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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
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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
§ 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.