← Product Code [LSL](/submissions/MI/subpart-d%E2%80%94serological-reagents/LSL) · K052224 # BD PROBE TEC URINE PRESERVATIVE TRANSPORT (K052224) _Becton, Dickinson & CO · LSL · Sep 12, 2005 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSL/K052224 ## Device Facts - **Applicant:** Becton, Dickinson & CO - **Product Code:** [LSL](/submissions/MI/subpart-d%E2%80%94serological-reagents/LSL.md) - **Decision Date:** Sep 12, 2005 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 866.3390 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## Intended Use The intended use of the BD ProbeTec ET CT/GC Amplified DNA Assays is unchanged. ## Device Story The BD ProbeTec ET system uses Strand Displacement Amplification (SDA) and fluorescent energy transfer (ET) to detect C. trachomatis and N. gonorrhoeae DNA in clinical specimens. The Urine Preservative Transport (UPT) kit, containing NAP Guard (K2EDTA), preserves urine samples for transport to testing sites. The system is operated by laboratory personnel. The device processes samples to provide qualitative results, which assist clinicians in diagnosing infections. The modification adds neat urine as a sample type and updates the UPT device materials and workflow. These changes aim to maintain or improve sensitivity and specimen stability compared to the predicate. ## Clinical Evidence Bench testing only. Comparison data provided for CT and GC assay results between the modified urine processing method and the predicate method to demonstrate equivalent performance. ## Technological Characteristics Uses homogeneous Strand Displacement Amplification (SDA) and fluorescent energy transfer (ET). UPT kit contains 50 µL of NAP Guard (742.5 mM K2EDTA) and a disposable transfer pipette. System is compatible with BD ProbeTec ET and BD Viper instruments. Connectivity is not specified. Sterilization method not stated. ## Regulatory Identification Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identify Neisseria spp. from cultured isolates. Additionally, some of these reagents consist of Neisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence of Neisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, 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. ## Predicate Devices - BD ProbeTec™ Urine Processing Pouch (UPP) Kit as cleared with the BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays ([K984631](/device/K984631.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} SPECIAL 510(k): Device Modification ODE Review Memorandum (Decision Making Document is Attached) To: THE FILE RE: DOCUMENT NUMBER K__052224 This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary): 1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) 2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use). The intended use of the BD ProbeTec ET CT/GC Amplified DNA Assays is unchanged. The urine processing kit is packaged separately and this labeling has been changed to describe the new urine processing procedure. 3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for: A new urine specimen processing method which utilizes a Urine Preservative Transport (UPT) tube or Neat Urine instead of a Urine Processing Pouch (UPP). 4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, specimen stability and comparison data for CT and GC assay results. 5. A Design Control Activities Summary which includes: a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied c) A declaration of conformity with design controls. The declaration of conformity should include: i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. 6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices). The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device. --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSL/K052224](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSL/K052224) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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