(27 days)
The BD ProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrohoeae Amplified DNA Assays, when tested with the BD ProbeTec ET System, uses Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis and N. gonorroheae, or of co-infection with both C. trachomatis and N. gonorroheae. Specimens may be from symptomatic and asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and the BD Viper™ instrument.
The BD ProbeTec™ Urine Preservative Transport Kit with NAP Guard™ technology is designed to preserve and transport Chlamydia trachomatis and Neisseria gonorrhoeae in male and female urine specimens from symptomatic and asymptomatic individuals prior to processing for analysis with the BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays.
The BD ProbeTec ET CT/GC amplified DNA assays utilize homogeneous SDA technology as the amplification method and fluorescent energy transfer (ET) as the detection method to test for the presence of CT and GC in clinical specimens.
The BD ProbeTec Urine Preservative Transport Kit with NAP Guard technology allows for an extended range of time and temperature conditions for storage and transport when testing for the presence of Chlamydia trachomatis and Neisseria gonorrhoeae in urine specimens using the BD ProbeTec ET CT and GC Amplified DNA Assays. Each UPT contains 50 µL of NAP Guard (2 M Guanidine Thiocyanate, 742.5 mM K2EDTA) packaged with a disposable transfer pipette. Urine is transferred to the UPT tube, mixed with the tube contents and transported to the test site for processing according to the assay package insert.
Below is a summary of the acceptance criteria and the study proving the device meets these criteria, based on the provided text:
Acceptance Criteria and Device Performance
This 510(k) submission is for modifications to the BD ProbeTec Urine Processing Pouch (UPP) and the addition of neat urine as a sample type. The key modifications assessed were: Materials Modification (affecting Specimen Stability), Input Specimen Volume Requirement (affecting Sensitivity), and Processing/Workflow Modification (affecting Assay Interference). The original BD ProbeTec ET CT/GC Amplified DNA Assays are the predicate device, and the modifications do not change the intended use of the assays.
The study compares the performance of the new BD ProbeTec™ Urine Preservative Transport (UPT) and neat urine sample types against the predicate UPP device.
| Parameter | Acceptance Criteria (Implied by Comparison to Predicate) | Reported Device Performance (UPT and Neat Urine) |
|---|---|---|
| Analytical Limit of Detection | Equivalent to or better than predicate UPP. | UPT and Neat urine sample types have analytical limits of detection equivalent to or better than UPP. |
| Interfering Substances | No significant impact on positive and negative assay results compared to predicate UPP. | Potential interferents have no significant impact to positive and negative assay results with UPT and Neat urine sample types. |
| Specimen Stability | UPT to exceed UPP stability; Neat urine stability to be established. | UPT specimen stability exceeds UPP specimen stability. Neat urine specimen stability is established. |
| Clinical Performance | Equivalent to predicate UPP. | UPT and Neat urine performance characteristics are equivalent to UPP. |
Study Details
The provided text describes comparison studies conducted to establish substantial equivalence for the modifications.
2. Sample Size and Data Provenance
The document does not explicitly state the sample sizes used for the test sets (comparison studies) for each parameter (Analytical Limit of Detection, Interfering Substances, Specimen Stability, Clinical Performance).
The data provenance is not explicitly stated (e.g., country of origin). The studies appear to be retrospective as they are comparisons to an already cleared predicate device (UPP) and involve evaluating different sample collection and processing methods, rather than following patients prospectively.
3. Number of Experts and Qualifications for Ground Truth of Test Set
The document does not mention the use of experts to establish ground truth for the test set. Given the nature of the device (in vitro diagnostic assay), the ground truth for performance characteristics like LoD, interference, and clinical performance would typically be established by laboratory reference methods or clinical diagnosis, not expert consensus on image interpretation.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. This is not typically applicable for laboratory-based in vitro diagnostic performance studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging devices or decision-support systems where human readers interpret data, and is not applicable to this in vitro diagnostic assay.
6. Standalone (Algorithm Only) Performance
Yes, the studies described are essentially standalone in terms of the analytical performance of the assay itself with the modified sample types. The tests evaluate the assay's ability to detect Chlamydia trachomatis and Neisseria gonorrhoeae DNA in urine samples collected and stored using the UPT or as neat urine, independently of human interpretation of the assay results. The "human-in-the-loop" aspect is largely limited to sample collection and laboratory processing, not interpretation of the assay's output.
7. Type of Ground Truth Used
The ground truth used for such in vitro diagnostic assays typically involves:
- Analytical LoD: Known concentrations of target analytes (e.g., bacterial DNA) prepared in a laboratory setting.
- Interfering Substances: Testing with known interfering substances added to samples that are negative or contain known concentrations of analytes.
- Specimen Stability: Testing samples with known analyte concentrations over time under specified storage conditions.
- Clinical Performance: Comparison against a gold standard (e.g., culture, another FDA-cleared molecular test considered highly accurate, or a composite reference method) using clinical specimens from symptomatic and asymptomatic individuals. While not explicitly stated as "clinical performance" ground truth, it's implied that the "clinical performance characteristics are equivalent" to the UPP, which would have established its own clinical ground truth.
8. Sample Size for the Training Set
The document does not provide information about a "training set" for the assay. This device is an in vitro diagnostic assay, not an AI/ML-based algorithm that typically requires a discrete training set. Therefore, the concept of a "training set" as understood in AI/ML is not directly applicable here. The assay's parameters would have been established and optimized during its development phase through internal validation studies, not a "training set" in the typical AI/ML sense.
9. How the Ground Truth for the Training Set was Established
As mentioned above, the concept of a "training set" does not directly apply to this in vitro diagnostic assay in the way it does for AI/ML models. For the initial development and optimization of the assay (which could be considered analogous to "training" in a broad sense), ground truth would have been established through a combination of:
- Spiked samples: Samples (e.g., urine) spiked with known quantities of C. trachomatis and N. gonorrhoeae DNA or whole organisms.
- Characterized clinical samples: Samples from patients with confirmed infections (e.g., by culture or established PCR methods) and uninfected individuals.
These would be used to optimize assay parameters such as primer design, reaction conditions, and detection thresholds, rather than to "train" an algorithm.
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K os224
510(k) SUMMARY
| SUBMITTED BY: | BECTON, DICKINSON AND COMPANY7 LOVETON CIRCLESPARKS, MD 21152 |
|---|---|
| CONTACT:TELEPHONE: | KATHRYN BABKA POWERS(410) 316-4260 |
| PREPARED: | September 7, 2005 |
| DEVICE NAME: | BD ProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrhoeaeAmplified DNA AssaysBD ProbeTec™ Urine Preservative Transport (UPT) |
| PREDICATEDEVICE: | BD ProbeTec™ Urine Processing Pouch (UPP) Kit as cleared with the BDProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC)Amplified DNA Assays (K984631) |
INTENDED USE:
The BD ProbeTec™ ET Chlamydia trachomatis and Neisseria governhoeae Amplified DNA The BD Probe Lec - ET Chiamyan Irachomans and Probections of Strand Displacement Ampilification Assays, when tested with the BD Froberted LT System, accommia trachomatis and Neisseria
(SDA) technology for the direct, qualitative detection of Chiamydia and male wrine (SDA) technology for the direct, qualitan's actorien of swabs, and in female and male urines, gonorrhoeae DNA in endocervical swars, marc arean and N. gonomoneer of oo infection with specimens as evidence of miection with C. ruchomans and en genesymptomatic and asymptomatic
both C. trachomatis and N. gonorroheae. Specimens may be from for the fina (BD both C. trachomans and M. gonorroneac. Open of in is an option for inhibition testing (BD)
females and males. A separate Amplification Donator Andress of CC occave may be per females and males. A separate Ampilitation Control is an of CT/GC assays may be performed ProbeTec ET CT/GC/AC Reagent Pack). The DD FrobeTee BT OF OF Street of System and the BD Viper™ instrument.
The BD ProbeTec™ Urine Preservative Transport Kit with NAP Guard™ technology is designed to The BD Probe lec" - Orme Preselvative Transport Kit Will a gonorrhoeae in male and female with the preserve and transport Chianyalu fractionalis and individuals prior to processing for analysis with the specimens from symplomatic and asymptomatic marriadal (GC) Amplified DNA Assays.
DEVICE DESCRIPTION:
The BD ProbeTec ET CT/GC amplified DNA assays utilize homogeneous SDA technology as the The BD Probe lec ET CT/CC ampillica DNA assays annot mores.
amplification method and fluorescent energy transfer (ET) as the detection method to test for the presence of CT and GC in clinical specimens.
The BD ProbeTec Urine Preservative Transport Kit with NAP Guard technology allows for an The BD Probe Lec Urine Preselvative Transport the with a storage and transport when testing extended range of time and telliperature concirculare in urine specimens using the for the presence of Chiangan muchomans and reason. Each UPT ontains 50 µL of NAP Guard (2
BD ProbeTec ET CT and GC Amplified DNA Assays. Each UPT ontains to the UPT 742.5 mM K2EDTA) packaged with a disposable transfer pipette. Urine is transferred to the UPT
742.5 mM K2EDTA) packaged with a disposable transfer pipette. Urine as transferr 742.5 mM K2EDTA) packaged with a disposable fransite pipettor - seen
tube, mixed with the tube contents and transported to the test site for processing according to the assay package insert.
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SUBSTANTIAL EQUIVALENCE:
This Special 510(k) is submitted for modifications to the BD ProbeTec Urine Processing Pouch This Special 510(k) is submitted ID Inounceanons of the works (CT) and Neisseria
(UPP) originally cleared with the BD ProbeTect 1000121) | The RD ProbeTec (UPP) originally cleared with the BD F100E ICC Chination includited device, the BD ProbeTec gonorrhoeae (GC) Amplified DNA Assay (C994031). The Inounled cornely arme specimens from
Urine Preservative Transport (UPT) is intel to the PD Probec FFC CT/AC Assays. No Urine Preservative Transport (OF I J IS Intended on testing with the BD ProbeTec ET CT/GC Assays. No
symptomatic or asymptomatic individuals in test CT/CT/GC Assays No symptomatic or asymptomatic individuals for testing with the BD ProbeTec ET CT/GC Amplified DNA Assays as a
changes in intended use are being made to the BD ProbeTec ET CT/GC result of this modification.
Also included in this Special 510(k) is the addition of neat urine without preservative) as a Also included in this Special 310(K) is the addition of the UPP device in the UPP device in that, under sample type with the CT/GC assays. Neat units and with a modification to the specimen processing.
restricted urine transport and storage conditions and with a mecimen process restricted urine transport and storage continues and with a mosted in the specimen processing procedure.
Modifications of the UPP device are as follows:
| Modification | Potential Impact of Modification |
|---|---|
| Materials Modification | Specimen Stability |
| Input Specimen Volume Requirement | Sensitivity |
| Processing/Workflow Modification | Assay Interference |
Risk analysis did not identify the changes as raising new issues of safety and effectiveness. The Risk and your were evaluated in comparison studies of the UPT device and Neat urine mat readyet class parameters listed below were evaluated in comparison stacted of the sample type met product claims for all parameters.
| Parameter | Result |
|---|---|
| Analytical Limit of Detection | UPT and Neat urine sample types haveanalytical limits of detection equivalent to orbetter than UPP. |
| Interfering Substances | Potential interferents have no significantimpact to positive and negative assay resultswith UPT and Neat urine sample types. |
| Specimen Stability | UPT specimen stability exceeds UPP specimenstability.Neat urine specimen stability is established. |
| Clinical Performance | UPT and Neat urine performancecharacteristics are equivalent to UPP. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure embracing a sphere, which symbolizes the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
SEP 1 2 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kathryn Babka Powers Regulatory Affairs Specialist BD Diagnostic Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
Re: K052224
. K032224
Trade/Device Name: BD ProbeTec™ ET CT/GC Amplified DNA Assays Regulation Number: 21 CFR 866.3390 Regulation Name: Neisseria spp. direct serological test reagents Regulatory Class: Class II Product Code: LSL, MKZ Dated: August 15, 2005 Received: August 16, 2005
Dear Ms. Powers:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave a rowe 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).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 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 (240)276-0484. 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/industry/support/index.html
Sincerely yours,
Sale, a Tory
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K052224
Device Name: BD ProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrohoeae Amplified DNA Assays
Indications For Use:
The BD ProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrohoeae The BD ProbeTec - when tested with the BD ProbeTec ET System, uses Amplifica Driver Association (SDA) technology for the direct, qualitative Strand Displacementis and Neisseria gonorrhoeae DNA in ucceenon of Chiamyana wabs, and in female and male urine specimens chaoce vical swably ma with C. trachomatis and N. gonorroheae, or of coas Cvidence of Infoction with entis and N. gonorroheae. Specimens may be from symptomatic and asymptomatic females and males. A separate Amplification Symptomation and abythr inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Control to an option to ET CT/GC assays may be performed using either the I ack). The BD Frooten or a combination of the BD ProbeTec ET System and the BD Viper™ instrument.
V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Fuddli L. Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
510(k) K052234
§ 866.3390
Neisseria spp. direct serological test reagents.(a)
Identification. Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identifyNeisseria spp. from cultured isolates. Additionally, some of these reagents consist ofNeisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence ofNeisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.(b)
Classification. Class II (performance standards).