(182 days)
Not Found
No
The document describes an automated sample preparation device using lysis and centrifugation. While it interfaces with a downstream mass spectrometry system (Bruker MALDI Biotyper CA System with MBT-CA Sepsityper software extension) for identification, the Accelerate Arc system itself is focused on physical sample processing and does not mention any AI or ML components in its operation or software. The identification and scoring are attributed to the Bruker system's software.
No
The device is an in vitro diagnostic device used for preparing concentrated microbial suspensions from blood culture samples for bacterial and yeast identification, aiding in the diagnosis of bloodstream infections. It does not directly provide therapy.
Yes
The device is explicitly stated to be an "in vitro diagnostic device" in the "Intended Use / Indications for Use" section. Furthermore, it is designed to aid in the diagnosis of bloodstream infections by preparing samples for microbial identification.
No
The device description explicitly states that the Accelerate Arc system is comprised of an automated sample preparation instrument (Accelerate Arc instrument), system software (Accelerate Arc system software), and sample preparation kit (Accelerate Arc BC kit). This includes hardware components (instrument and kit) in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Accelerate Arc system is an in vitro diagnostic device..."
- Purpose: The device is intended to prepare samples from positive blood cultures to aid in the diagnosis of bloodstream infections. This is a diagnostic purpose.
- In Vitro: The sample preparation and subsequent analysis with the Bruker system are performed outside of the human body (in vitro).
- Clinical Laboratory Use: The device is intended for use by trained healthcare professionals in clinical laboratories, which is a typical setting for IVD devices.
- Aids in Diagnosis: The output of the system (microbial identification) is used in conjunction with other clinical and laboratory findings to aid in diagnosis.
Therefore, based on the provided text, the Accelerate Arc system clearly meets the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Accelerate Arc system is an automated sample preparation device that uses lysis and centrifugation to prepare concentrated microbial suspensions from positive blood culture samples that can be used for bacterial and yeast identification with the Bruker MALDI Biotyper CA System (MBT-CA System) with MBT-CA Sepsityper software extension. Samples are processed directly from BD BACTEC blood culture bottles identified as positive by a continuous monitoring blood culture system. Samples should be confirmed as monomicrobial by Gram stain.
The Accelerate Arc system is an in vitro diagnostic device comprised of the Accelerate Arc system software, and the Accelerate Arc BC kit. The Accelerate Arc BC kit is a disposable consumable that includes reagents to concentrate and purify microbial cells from positive blood culture samples.
Microbial suspensions prepared by the Accelerate Arc system can be used to identify bacterial species and yeasts in accordance with the Bruker MBT-CA reference library.
Subculture of positive blood culture is necessary to recover organisms not identified by the Bruker with MBT-CA Sepsityper software extension, species not indicated for testing with the Bruker MBT-CA System with MBT-CA Sepsityper software extension, for susceptibility testing, and for differentiation/recovery of organisms present in polymicrobial samples.
The Accelerate Arc system is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory findings, including Gram staining, to aid in the diagnosis of bloodstream infections.
Product codes
QNJ
Device Description
The Accelerate Arc system is an automated sample preparation device with associated consumables that uses lysis and centrifugation to prepare microbial suspensions from positive blood culture (PBC) samples from BD BACTEC™ bottles that have rung positive on a continuous monitoring system and confirmed to be monomicrobial by Gram stain. Suspensions containing concentrated, monomicrobial microorganisms are intended for use with the downstream mass spectrometry (MS) analyzer Bruker MALDI Biotyper® CA System with MBT-CA Sepsityper® software extension for qualitative identification and differentiation of microorganisms to aid in the early diagnosis of bacterial and yeast infections. This device is comprised of an automated sample preparation instrument (Accelerate Arc instrument), system software (Accelerate Arc system software), and sample preparation kit (Accelerate Arc BC kit).
The Accelerate Arc system was designed to standardize workflow to minimize operator error and variability. The Accelerate Arc instrument, system software and BC kit rapidly clean up and concentrate microorganisms from positive blood culture samples for downstream identification of the microorganism using the Bruker MALDI Biotyper® CA System with MBT-CA Sepsityper® software extension. The confidence score range from the MBT-CA Sepsityper® software extension is used to denote high confidence (1.8 to 3), low confidence (1.6 to 1.79), and no identification (0 to 1.59). Altogether, rapid microorganism identification direct from PBC can be achieved in about 1 ½ hours following this workflow.
The maximum system configuration of eight Accelerate Arc modules can process greater than 150 PBCs in a single day.
The Accelerate ArcTM system is comprised of:
- . Accelerate Arc™ instrument
- Accelerate Arc™ system software .
- . Accelerate Arc™ BC kit
Samples prepared by the Accelerate Arc system are intended for use with:
Bruker MALDI Biotyper® CA System with MBT-CA Sepsityper® software . extension
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals in clinical 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
Samples for evaluation of Accelerate Arc system performance were collected from three (3) clinical sites: In total, 343 specimens were evaluated for performance, 99 fresh prospective and 244 contrived. Altogether 41 different species were identified during the clinical tests. 172 Gram negative isolates, 154 Gram positive isolates, and 17 yeast isolates (Table 9).
For all PBC samples processed using the Accelerate Arc system. Direct Transfer (DT) and extended Direct Transfer (eDT) workflows were applied with final results interpretation being "DT PLUS eDT" [best log(score) is used for the final result] according to MBT-CA System with MBT-CA Sepsityper software extension analysis and interpretation of results.
Fresh sample testing was performed at two external clinical sites and contrived testing was performed at two external sites and one internal site. Each sample was processed using the Accelerate Arc system and prepared for MBT-CA System and MBT-CA Sepsityper software extension analysis using the MBT-CA System DT and eDT workflows. The final log score and identification result for each sample used for performance evaluation was the highest of the DT and eDT test results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Analytical Performance; Method Comparison
Precision/Reproducibility:
This study used 10 different organisms commonly found in PBC samples, tested in replicates of 3 across 3 non-consecutive days at a total of 3 sites. Isolates were contrived in blood culture bottles containing whole blood from healthy donors, incubated on the BD BACTECTM continuous blood culture monitoring system until positive, and then PBC samples run with the Accelerate Arc system. Three Accelerate Arc instruments, and three different Accelerate Arc BC kit lots were used for each group of triplicate replicates tested per organism on each day. Two operators executed testing on alternate days. Overall, 96% of all samples tested produced a High or Low confidence ID result and no incorrect identifications were observed using the DT PLUS eDT workflow.
Detection Limit:
Five representative microbial species (Staphylococcus aureus, Streptococcus agalactiae, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Candida tropicalis) were used to contrive PBCs using fresh donor blood incubated in the BD BACTECTM continuous blood culture monitoring system until positive.
Ten replicate samples per species were run immediately after flagging positive (at positivity) using the Accelerate Arc system.
A second set of 10 replicate samples per species was run after a 1:10 dilution into a negative blood culture sample.
For PBCs containing bacterial organisms there is sufficient biological material at positivity for successful identification. For blood cultures containing yeast organisms, ID was successful after incubation of the PBC for approximately one hour. For samples diluted 1:10, a lower concentration of microorganisms in test samples does not produce any false identifications.
Sample Stability:
Four representative microbial species (Klebsiella pneumonia, Staphylococcus aureus, Candida tropicalis, and Haemophilus influenzae) were used to contrive positive blood cultures using fresh donor blood incubated in the BD BACTECTM continuous blood culture monitoring system until positive.
Post-Positive sample stability: tested using blood culture samples incubated for up to 16 hours inside the blood culture incubation system or up to 24 hours outside at ambient temperature. Testing at all extended incubation conditions produced reportable and accurate results.
Post-Processing sample stability: tested using samples stored for up to 8 hours at 2-8°C (refrigerated) and at ambient temperature after Accelerate ArcTM system processing. Testing at extended incubation conditions generally produced reportable and accurate results.
Post-Matrix sample stability: tested using samples stored for up to 24 hours at ambient temperature after addition of matrix (HCCA) to analyte spots on the MALDI-ToF target plate. Testing at all extended incubation conditions produced reportable and accurate results.
Blood Culture Bottle Type Compatibility:
Five representative microbial species (Staphylococcus aureus, Streptococcus agalactiae, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Candida tropicalis) were used to contrive PBCs using fresh donor blood incubated in the BD BACTEC continuous blood culture monitoring system until positive. Seven different BD BACTEC blood culture media bottle types were used.
No difference in performance was observed for any bottle type for Gram-negative organisms. Lower performance was observed with Staphylococcus aureus and Streptococcus agalactiae only for the Myco/F Lytic bottles. Lower performance was observed with Candida tropicalis but only for the Standard Aerobic and Standard Anaerobic bottles.
Carry-over/Cross Contamination:
Six different microbial species (three GN and three GP) were used to contrive PBCs. A negative blood culture bottle was also used. Alternating positive and negative blood culture samples were processed across three different Accelerate Arc modules. Positive and negative blood culture samples processed using the Accelerate Arc system were also spotted side-by-side using the 48-spot reusable MBT Biotarget plate and the 96-spot disposable MBT Biotarget plate.
No evidence of carry-over or cross contamination was observed from back-to-back Accelerate Arc system runs or between side-by-side analyte spots on the target plates.
Interfering Substances:
Three representative microbial species (Klebsiella pneumoniae, Staphylococcus aureus, and Candida tropicalis) were used to contrive PBCs using fresh donor blood. PBCs containing interfering substances (routine blood/blood culture media interferents and drug interferents) were processed.
No inaccurate identification results were observed from testing of PBC with drug and antibiotic interfering substances at target concentrations.
For routine blood and blood culture media interferents, all but two substances (Protein and WBC) showed no evidence of interference. Candida tropicalis performance was negatively affected by "Protein" at 120 g/L, but retesting at 60 g/L yielded accurate results. Performance across all organisms was negatively affected by WBC at 1.5x10^10 cells/L, but accurate ID results were achieved at 3.75x10^9 cells/L.
Polymicrobial Interference:
PBC samples were contrived using fresh, negative donor blood, inoculated with representative organisms, and incubated until positive. Polymicrobial mixtures were prepared at five different concentration ratios (5:0, 5:1, 1:1, 1:5, 0:5) containing two different representative microbial species.
No inaccurate identification results were observed. All control tests (5:0 and 0:5 ratio conditions) produced accurate and reportable ID results. Results from PBC samples containing two different microbial species (5:1, 1:1, 1:5) produced either accurate reportable ID results or no identification results. Reportable ID results corresponded to accurate species identification of at least one of the test organisms.
Method Comparison:
Samples: 343 specimens (99 fresh prospective, 244 contrived) from 3 clinical sites. 41 different species identified (172 Gram negative, 154 Gram positive, 17 yeast).
Workflow: Accelerate Arc system processed samples, then Direct Transfer (DT) and extended Direct Transfer (eDT) workflows with Bruker MBT-CA System and MBT-CA Sepsityper software extension. Final result interpretation used "DT PLUS eDT" (best log(score) is used).
Accuracy: 100% accuracy from reportable identification results using Accelerate Arc-prepared samples and MBT-CA with Sepsityper software extension analysis with MBT-CA System "DT PLUS eDT" workflow.
Performance by Organism Type:
- Gram-negative (GN): ~90% to ~99% of samples producing a High or Low confidence ID result.
- Gram-positive (GP): ~93% in contrived samples, ~78% in fresh samples.
- Yeast: lowest, less than ~67% of contrived samples, no ID from fresh samples.
Overall Performance: Combined performance across all organism types was around ~91% of all samples tested producing a high or low confidence result and ~85% of all samples producing a high confidence identification result.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for reporting rates (High confidence, High & Low confidence, No ID). Specific metrics like Sensitivity, Specificity, PPV, NPV are not explicitly provided.
Predicate Device(s)
MBT Sepsityper, K193419
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3378 Clinical mass spectrometry microorganism identification and differentiation system.
(a)
Identification. A clinical mass spectrometry microorganism identification and differentiation system is a qualitative in vitro diagnostic device intended for the identification and differentiation of microorganisms from processed human specimens. The system acquires, processes, and analyzes spectra to generate data specific to a microorganism(s). The device is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infection.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The intended use statement must include a detailed description of what the device detects, the type of results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended, when applicable.
(2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt with an indication for in vitro diagnostic use.
(3) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed device description, including all device components, control elements incorporated into the test procedure, instrument requirements, ancillary reagents required but not provided, and a detailed explanation of the methodology and all pre-analytical methods for processing of specimens, and algorithm used to generate a final result. This must include a description of validated inactivation procedure(s) that are confirmed through a viability testing protocol, as applicable.
(ii) Performance characteristics for all claimed sample types from clinical studies with clinical specimens that include prospective samples and/or, if appropriate, characterized samples.
(iii) Performance characteristics of the device for all claimed sample types based on analytical studies, including limit of detection, inclusivity, reproducibility, interference, cross-reactivity, interfering substances, carryover/cross-contamination, sample stability, and additional studies regarding processed specimen type and intended use claims, as applicable.
(iv) A detailed explanation of the interpretation of test results for clinical specimens and acceptance criteria for any quality control testing.
(4) The device's labeling must include a prominent hyperlink to the manufacturer's website where the manufacturer must make available their most recent version of the device's labeling required under § 809.10(b) of this chapter, which must reflect any changes in the performance characteristics of the device. FDA must have unrestricted access to this website, or manufacturers must provide this information to FDA through an alternative method that is considered and determined by FDA to be acceptable and appropriate.
(5) Design verification and validation must include:
(i) Any clinical studies must be performed with samples representative of the intended use population and compare the device performance to results obtained from an FDA-accepted reference method and/or FDA-accepted comparator method, as appropriate. Documentation from the clinical studies must include the clinical study protocol (including predefined statistical analysis plan, if applicable), clinical study report, and results of all statistical analyses.
(ii) Performance characteristics for analytical and clinical studies for specific identification processes for the following, as appropriate:
(A) Bacteria,
(B) Yeasts,
(C) Molds,
(D) Mycobacteria,
(E) Nocardia,
(F) Direct sample testing (
e.g., blood culture),(G) Antibiotic resistance markers, and
(H) Select agents (
e.g., pathogens of high consequence).(iii) Documentation that the manufacturer's risk mitigation strategy ensures that their device does not prevent any device(s) with which it is indicated for use, including incorporated device(s), from achieving their intended use (
e.g., safety and effectiveness of the functions of the indicated device(s) remain unaffected).(iv) A detailed device description, including the following:
(A) Overall device design, including all device components and all control elements incorporated into the testing procedure.
(B) Algorithm used to generate a final result from raw data (
e.g., how raw signals are converted into a reported result).(C) A detailed description of device software, including validation activities and outcomes.
(D) Acquisition parameters (
e.g., mass range, laser power, laser profile and number of laser shots per profile, raster scan, signal-to-noise threshold) used to generate data specific to a microorganism.(E) Implementation methodology, construction parameters, and quality assurance protocols, including the standard operating protocol for generation of reference entries for the device.
(F) For each claimed microorganism characteristic, a minimum of five reference entries for each organism (including the type strain for microorganism identification), or, if there are fewer reference entries, a clinical and/or technical justification, determined by FDA to be acceptable and appropriate, for why five reference entries are not needed.
(G) DNA sequence analysis characterizing all type strains and at least 20 percent of the non-type strains of a species detected by the device, or, if there are fewer strain sequences, then a clinical and/or technical justification, determined by FDA to be acceptable and appropriate, must be provided for the reduced number of strains sequenced.
(H) As part of the risk management activities, an appropriate end user device training program, which must be offered as an effort to mitigate the risk of failure from user error.
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September 26, 2024
Accelerate Diagnostics Inc. % Jo-Ann Gonzales Senior Director, IVD Regulatory Consulting Precision for Medicine, Inc. 2 Bethesda Metro Center, Suite 850 Bethesda, Maryland 20814
Re: K240854
Trade/Device Name: Accelerate Arc System Regulation Number: 21 CFR 866.3378 Regulation Name: Clinical Mass Spectrometry Microorganism Identification And Differentiation System Regulatory Class: Class II Product Code: QNJ Dated: August 29, 2024 Received: August 29, 2024
Dear Jo-Ann Gonzales:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Branch Chief, General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K240854
Device Name Accelerate Arc system
Indications for Use (Describe)
The Accelerate Arc system is an automated sample preparation device that uses lysis and centrifugation to prepare concentrated microbial suspensions from positive blood culture samples that can be used for bacterial and yeast identification with the Bruker MALDI Biotyper CA System (MBT-CA System) with MBT-CA Sepsityper software extension. Samples are processed directly from BD BACTEC blood culture bottles identified as positive by a continuous monitoring blood culture system. Samples should be confirmed as monomicrobial by Gram stain.
The Accelerate Arc system is an in vitro diagnostic device comprised of the Accelerate Arc system software, and the Accelerate Arc BC kit. The Accelerate Arc BC kit is a disposable consumable that includes reagents to concentrate and purify microbial cells from positive blood culture samples.
Microbial suspensions prepared by the Accelerate Arc system can be used to identify bacterial species and yeasts in accordance with the Bruker MBT-CA reference library.
Subculture of positive blood culture is necessary to recover organisms not identified by the Bruker with MBT-CA Sepsityper software extension, species not indicated for testing with the Bruker MBT-CA System with MBT-CA Sepsityper software extension, for susceptibility testing, and for differentiation/recovery of organisms present in polymicrobial samples.
The Accelerate Arc system is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory findings, including Gram staining, to aid in the diagnosis of bloodstream infections.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
- Date Prepared: A. September 24, 2024
- B. Measurand: See Indications for Use
- C. Type of Test
The Accelerate Arc™ system, comprised of the Accelerate Arc instrument (including the Accelerate Arc module, a computing system, a touchscreen monitor, and a barcode reader), Accelerate Arc system software, and Accelerate Arc BC kit for use with Bruker's MALDI Biotyper® CA System (MBT-CA System) and MBT-CA Sepsityper® software extension, is a qualitative in vitro diagnostic device for species identification of Gram positive and negative bacteria and yeasts in positive blood cultures from BD BACTEC™ bottles.
D. Submitter Information:
| Submitted By: | Accelerate Diagnostics, Inc.
3950 South Country Club Rd, Suite 470 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jack Phillips
Chief Executive Officer/Head of Regulatory Affairs
Accelerate Diagnostics, Inc.
Tel: 1-520-365-3100
Fax: 1-520-269-6580
Email: jphillips@axdx.com |
| Primary Regulatory Contact: | Jo-Ann Gonzales, RAC
Senior Director, IVD Regulatory Consulting
Precision for Medicine
2 Bethesda Metro Center, Suite 850
Bethesda, MD 20184
Tel: 1-510-376-2590
Email: jo-ann.gonzales@precisionformedicine.com |
E. Proprietary and Established Names:
| Trade Name: | Accelerate ArcTM system |
|---|---|
| Common Name: | Blood culture processing device that includes associated reagents |
| that are intended to concentrate and purify microbial cells from | |
| blood culture samples identified as positive by a continuous | |
| monitoring blood culture system with organisms subsequently | |
| identified by spectrometry. |
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F. Regulatory Information:
-
- Classification Name: 866.3378 - Clinical mass spectrometry microorganism identification and differentiation system
-
- Product Code: ONJ
- MI (Microbiology) 3. Panel:
- Class II 4. Device Class:
G. Intended Use/Indications for Use
-
- Intended Use
See Indications for Use.
- Intended Use
-
- Indications for Use
The Accelerate ArcTM system is an automated sample preparation device that uses lysis and centrifugation to prepare concentrated microbial suspensions from positive blood culture samples that can be used for bacterial and yeast identification with the Bruker MALDI Biotyper® CA System (MBT-CA System) with MBT-CA Sepsityper® software extension. Samples are processed directly from BD BACTEC™ blood culture bottles identified as positive by a continuous monitoring blood culture system. Samples should be confirmed as monomicrobial by Gram stain.
- Indications for Use
The Accelerate Arc system is an in vitro diagnostic device comprised of the Accelerate Arc instrument, Accelerate Arc system software, and the Accelerate Arc BC kit. The Accelerate Arc BC kit is a disposable consumable that includes reagents to concentrate and purify microbial cells from positive blood culture samples.
Microbial suspensions prepared by the Accelerate Arc system can be used to identify bacterial species and yeasts in accordance with the Bruker MBT-CA reference library.
Subculture of positive blood culture is necessary to recover organisms not identified by the Bruker MBT-CA System with MBT-CA Sepsityper software extension, species not indicated for testing with the Bruker MBT-CA System with MBT-CA Sepsityper software extension, for susceptibility testing, for epidemiologic testing, and for differentiation/recovery of organisms present in polymicrobial samples.
The Accelerate Arc system is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory findings, including Gram staining, to aid in the diagnosis of bloodstream infections.
-
- Special conditions for use statement(s):
Rx - For Prescription Use Only
- Special conditions for use statement(s):
6
IVD – For In Vitro Diagnostic Use Only
-
- Special instrument requirements:
MALDI Biotyper® CA System with MBT-CA Sepsityper® software extension
- Special instrument requirements:
H. Device/System Characteristics:
-
- Device Description:
The Accelerate Arc system is an automated sample preparation device with associated consumables that uses lysis and centrifugation to prepare microbial suspensions from positive blood culture (PBC) samples from BD BACTEC™ bottles that have rung positive on a continuous monitoring system and confirmed to be monomicrobial by Gram stain. Suspensions containing concentrated, monomicrobial microorganisms are intended for use with the downstream mass spectrometry (MS) analyzer Bruker MALDI Biotyper® CA System with MBT-CA Sepsityper® software extension for qualitative identification and differentiation of microorganisms to aid in the early diagnosis of bacterial and yeast infections. This device is comprised of an automated sample preparation instrument (Accelerate Arc instrument), system software (Accelerate Arc system software), and sample preparation kit (Accelerate Arc BC kit).
- Device Description:
The Accelerate Arc system was designed to standardize workflow to minimize operator error and variability. The Accelerate Arc instrument, system software and BC kit rapidly clean up and concentrate microorganisms from positive blood culture samples for downstream identification of the microorganism using the Bruker MALDI Biotyper® CA System with MBT-CA Sepsityper® software extension. The confidence score range from the MBT-CA Sepsityper® software extension is used to denote high confidence (1.8 to 3), low confidence (1.6 to 1.79), and no identification (0 to 1.59). Altogether, rapid microorganism identification direct from PBC can be achieved in about 1 ½ hours following this workflow.
The maximum system configuration of eight Accelerate Arc modules can process greater than 150 PBCs in a single day.
The Accelerate ArcTM system is comprised of:
- . Accelerate Arc™ instrument
- Accelerate Arc™ system software .
- . Accelerate Arc™ BC kit
Samples prepared by the Accelerate Arc system are intended for use with:
Bruker MALDI Biotyper® CA System with MBT-CA Sepsityper® software . extension
-
- Principle of Operation:
The Accelerate Arc BC kit contains a sample capsule and reagent cartridge. Positive blood culture (PBC) sample processing is performed on the Accelerate Arc instrument ,
- Principle of Operation:
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which uses automated fluid handling and centrifugation in conjunction with Accelerate Arc system software to prepare PBC samples for subsequent organism identification using MALDI-ToF MS. The user loads the PBC sample into the sample capsule, scans the reagent cartridge barcode using the provided handheld barcode scanner, places the reagent cartridge and sample capsule into an Accelerate Arc module and closes the module door to start the run. The rest of the operations are automated as described below.
Single-Use Consumables
The Accelerate Arc BC kit includes a single-use, disposable capsule and reagent cartridge. The user loads the sample into the capsule and seals with the provided cap. The capsule is then inserted into the Accelerate Arc module along with the reagent cartridge. The capsule was designed for efficient sample pelleting along its equator (middle of the capsule) during centrifugation.
Centrifugation
Inline centrifugation is used to sediment microorganisms contained in liquid samples. It performs a separation in which the microorganisms are concentrated in an equatorial pellet within the capsule and the fluid component forms a subnatant. The subnatant is then removed by aspiration, dispensed to a waste well, and replaced with clean fluid. This process is repeated multiple times with fresh reagents. By these means, blood, cellular debris, and culture media matrix components are reduced from the sample.
Fluid Handling
Fluid handling is performed within the Accelerate Arc module by means of an automated pipetting system. The pipetting system uses disposable tips included in the kit to access and transfer liquid reagents in the reagent cartridge to and from the capsule.
Resuspension
Resuspension is accomplished in the Accelerate Arc module by performing lower speed spins in which the direction of rotation is repeatedly reversed. The rapid reversals of the rotor generate shear within the fluid that acts on the pellet to lift it off the capsule wall and allows its resuspension in the fresh reagent fluid dispensed by the Arc module.
I. Instrument Description Information:
1. Instrument Name:
Accelerate Arc system (Accelerate Arc instrument, system software, and BC kit)
2. Specimen Identification:
The user can use the Accelerate Arc instrument's barcode reader or manually enter the specimen identification and Accelerate Arc BC kit information into the system at the start of a run. This information is required before the run can proceed.
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- Specimen Sampling and Handling: Below is a summary of the procedure and is detailed in the Instructions for Use:
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- Vortex blood culture bottle for 10 sec. Vent bottle and transfer 1.7 mL ± 0.2 mL of positive blood culture media using a 3 mL syringe and 21-23g needle (or equivalent) into a labeled and uncapped Arc capsule, then cap.
Note: PBCs must be processed up to 16 hours after positivity if kept on the blood culture instrument or up to 24 hours if kept at room temperature.
- Vortex blood culture bottle for 10 sec. Vent bottle and transfer 1.7 mL ± 0.2 mL of positive blood culture media using a 3 mL syringe and 21-23g needle (or equivalent) into a labeled and uncapped Arc capsule, then cap.
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- Select an available Arc module and scan or enter the barcode information.
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- Load the capped and labeled Arc sample capsule and Arc reagent cartridge with the adhesive sticker removed into the selected Arc module.
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- Close the Arc module door and select run sample on the user interface.
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- Upon run completion, press the Arc module button to unlock the door to dispose of the reagent cartridge.
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- Vortex the capped Arc sample capsule prior to subsequent MALDI Biotyper CA System microbial identification.
Note: The Arc-processed PBC sample is stable for up to 8 hours refrigerated or room temperature prior to spotting on target plate.
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- Determine microbial identification of the Arc processed sample on the MBT-CA System with MBT-CA Sepsityper software extension.
- Add 1 ul of the Arc-processed sample to two sequential spots (DT and eDT) a. on a target plate and allow spots to completely dry.
- b. Add 1 ul of 70% formic acid to ONLY the second test spot (eDT).
- Spot the US IVD BTS onto two target plate positions following Instructions C. for Use for the US IVD BTS and allow spots to completely dry.
- d. Overlay each test and BTS spots with 1 ul of US IVD HCCA matrix solution and allow all spots to completely dry.
Note: Target plates can be kept at room temperature for up to 24 hours prior to MALDI identification.
- e. Record the test spots in the Bruker software.
- Insert the target plate into the Bruker MBT-CA System and run through the f. MBT-CA Sepsityper identification process following the Bruker User Manual of MBT-CA System.
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- Calibration:
Calibration is only performed at time of installation and preventative maintenance visits by an Accelerate Diagnostics, Inc. trained field service engineer when warranted. There is no calibration required by the user for the Accelerate Arc system.
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Accelerate Arc system quality checks are hardware performance checks performed throughout each run to ensure the system is functioning as expected. All quality checks must pass for successful run completion, indicating the sample has been processed to procedure specification. In the event of a quality check failure, the sample has NOT been processed per specification.
No external quality control check of kit consumables is required by the user.
5. Quality Control:
The user will follow local, state and/or federal regulations for Quality Control requirements.
J. Substantial Equivalence Information
- MBT Sepsityper 1. Predicate Device Name:
- K193419 2. Predicate 510(k) Number:
-
- Comparison with Predicate:
A comparison of the features of the Accelerate Arc system and the MBT Sepsityper, predicate device, are as provided in Table 1.
Table 1: Substantial Equivalence Table
| | Proposed Device
(Accelerate Arc system, K240854) | Predicate
(MBT Sepsityper, K193419) |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications
for Use | The Accelerate ArcTM system is an automated
sample preparation device that uses lysis and
centrifugation to prepare concentrated
microbial suspensions from positive blood
culture samples that can be used for bacterial
and yeast identification with the Bruker
MALDI Biotyper® CA System (MBT-CA
System) with MBT-CA Sepsityper® software
extension. Samples are processed directly from
BD BACTECTTM blood culture bottles identified
as positive by a continuous monitoring blood
culture system. Samples should be confirmed as
monomicrobial by Gram stain.
The Accelerate Arc system is an in vitro
diagnostic device comprised of the Accelerate
Arc instrument, Accelerate Arc system
software, and the Accelerate Arc BC kit. The
Accelerate Arc BC kit is a disposable
consumable that includes reagents to
concentrate and purify microbial cells from
positive blood culture samples. | The MBT Sepsityper is a qualitative in vitro
diagnostic device consisting of a MBT-CA
(Sepsityper) software extension and a reagent kit
(MBT Sepsityper Kit US IVD) for use in
conjunction with other clinical and laboratory
findings to aid in the early diagnosis of bacterial and
yeast infections from positively flagged blood
cultures using the MALDI Biotyper CA System.
The MBT Sepsityper Kit US IVD is a disposable
blood culture processing device that includes
associated reagents that are intended to concentrate
and purify microbial cells from blood culture
samples identified as positive by a continuous
monitoring blood culture system and confirmed to
demonstrate the presence of a single organism as
determined by Gram stain. This sample preparation
manual method is performed by laboratory health
professionals in a clinical diagnostic setting.
Subculturing of positive blood cultures is necessary
to recover organisms for identification of organisms
not identified by the MBT-CA System, for
susceptibility testing and for differentiation of
mixed growth. Positive MBT Sepsityper results do |
| | Proposed Device
(Accelerate Arc system, K240854) | Predicate
(MBT Sepsityper, K193419) |
| | Microbial suspensions prepared by the
Accelerate Arc system can be used to identify
bacterial species and yeasts in accordance with
the Bruker MBT-CA reference library.
Subculture of positive blood culture is
necessary to recover organisms not identified
by the Bruker MBT-CA System with MBT-CA
Sepsityper software extension, species not
indicated for testing with the Bruker MBT-CA
System with MBT-CA Sepsityper software
extension, for susceptibility testing, for
epidemiologic testing, and for
differentiation/recovery of organisms present in
polymicrobial samples.
The Accelerate Arc system is intended for use
by trained healthcare professionals in clinical
laboratories in conjunction with other clinical
and laboratory findings, including Gram
staining, to aid in the diagnosis of bloodstream
infections. | not rule out co-infection with organisms that may
not be detected by the MBT-CA System. Results of
the MBT Sepsityper should not be used as the sole
basis for diagnosis, treatment, or other patient
management decisions. Results of the MBT
Sepsityper should be correlated with Gram stain
results and used in conjunction with other clinical
and laboratory findings to aid in the diagnosis of
bacterial and yeast bloodstream infections.
See MBT Sepsityper FDA decision summary
(K193419) for organisms recovered from positive
blood culture bottles that are suitable for
identification using the MBT Sepsityper. |
| Classification | Class II | Same |
| Product Code | QNJ | Same |
| Regulation | 21 CFR 866.3378 - Mass Spectrometry, Maldi
Tof, Microorganism Identification, Cultured
Isolates | Same |
| Type of Test | Sample processing device for use with mass
spectrometry system | Mass spectrometry system |
| Matrix | α-Cyano-4-hydroxycinnamic acid | Same |
| Matching
Algorithm | Arc-prepared samples are tested with the MBT-
CA System with MBT-CA Sepsityper software
extension matching algorithm | Calculates matches by comparing a new spectrum
against each single reference entry of a reference
database. |
| Sample Type | Positive blood cultures | Same |
| Sample Volume | 1.7ml +/- 0.2ml | 1ml |
| Test
Sample/Validated
Blood Culture
Bottles | The following positively flagged BD
BACTECT™ blood culture bottles:
• BD BACTECT™ Standard - Aerobic /
Anaerobic
• BD BACTECT™ PLUS - Aerobic / Anaerobic
• BD BACTECT™ - Lytic Anaerobic
• BD BACTECT™ - BD Peds Plus™
• BD BACTECT™ - Myco/F Lytic | Bottles of the BD BACTECT™ (Becton Dickinson)
System:
• BD BACTECT™ Standard - Aerobic / Anaerobic
• BD BACTECT™ PLUS - Aerobic / Anaerobic
• BD BACTECT™ - Lytic Anaerobic
• BD BACTECT™ - BD Peds Plus™
• BD BACTECT™ - Myco/F Lytic
• BD BACTECT™ - Mycosis IC
Bottles without charcoal of the BacT/ALERT®
(bioMérieux) System:
• BacT/ALERT® SA Standard Aerobic
• BacT/ALERT® SN Standard Anaerobic
• BacT/ALERT® FA Plus |
| | Proposed Device
(Accelerate Arc system, K240854) | Predicate
(MBT Sepsityper, K193419) |
| | | • BacT/ALERT® FN Plus
• BacT/ALERT® PF Plus |
| | | Bottles of the VersaTREK® (Thermo Scientific) System:
• VersaTREK® REDOX 1
• VersaTREK® REDOX 2 |
| Sample
Preparation
Instrument | Accelerate Arc instrument | None |
| Sample
Preparation
Instrument
Software | Accelerate Arc system software | N/A |
| Sample
Preparation Kit | Accelerate Arc BC kit | MBT Sepsityper Kit US IVD |
| MALDI-ToF MS
Instrument | Intended for use with the Bruker MBT-CA System with MBT-CA Sepsityper software extension | MALDI Biotyper® (MBT) CA System |
| MALDI-ToF MS
Instrument
Software | Intended for use with the Bruker MBT-CA System with MBT-CA Sepsityper software extension | MBT-CA System software with reference library and the MBT-CA (Sepsityper) software extension |
| Reference
Library | Intended for use with the Bruker MBT-CA System with MBT-CA Sepsityper software extension | MALDI Biotyper® (MBT) CA System |
| Analyzed Mass
Range | Intended for use with the Bruker MBT-CA System with MBT-CA Sepsityper software extension | 4,000 - 15,000 m/z (Sepsityper samples) |
| Mix Culture Hint | Intended for use with the Bruker MBT-CA System with MBT-CA Sepsityper software extension | Yes |
| MALDI Target
Plate | Intended for use with the Bruker MBT-CA System with MBT-CA Sepsityper software extension | US IVD 48 Spot Target (48 positions reusable steel targets)
MBT Biotarget 96 US IVD (96 positions disposable targets) |
| Calibration and
Quality Control | Intended for use with the Bruker MBT-CA System with MBT-CA Sepsityper software extension | Bruker US IVD Bacterial Test Standard (BTS) |
| MALDI
Workflow | The approved DT and eDT MBT-CA System Workflow (same as predicate) plus the Accelerate Arc system and Accelerate Arc BC kit Workflow | The approved MBT-CA Workflow plus the MALDI Sepsityper Workflows [Rapid Sepsityper DT (RS_DT), Rapid Sepsityper eDT (RS_eDT) and Full Sepsityper (Ext)] |
| log(score) Values | Intended for use with the Bruker MBT-CA System with MBT-CA Sepsityper software extension | MBT Sepsityper Samples:
• High Confidence ID: 1.80 - 3.00;
• Low Confidence ID: 1.60 - 1.79;
• No Organism ID Possible: 0.00 - 1.59 |
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Image /page/11/Picture/0 description: The image shows the logo for Accelerate Diagnostics. The logo consists of a blue geometric shape on the left, followed by the word "ACCELERATE" in gray, and the word "DIAGNOSTICS" in blue below it. Below the logo, the text "Accelerate Arc system" is written in black.
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K. Standards/Guidance Documents Referenced
None.
L. Test Principle
Organisms to be identified with the Bruker MALDI Biotyper CA System (MBT-CA System) and MBT-CA Sepsityper software extension are processed beforehand using the Accelerate Arc system with positive blood culture samples. Users are instructed to test the Arc processed sample on the Bruker MBT-CA System with MBT-CA Sepsityper software extension using both the direct transfer (DT) and extended direct transfer (eDT) techniques following the steps described in the Bruker MALDI Biotyper CA System User Manual to operate the MBT-CA System and MBT-CA Sepsityper identification process to report results.
M. Performance Characteristics
1. Analytical Performance
- a. Precision/Reproducibility:
This study used 10 different organisms commonly found in PBC samples, tested in replicates of 3 across 3 non-consecutive days at a total of 3 sites. Isolates were contrived in blood culture bottles containing whole blood from healthy donors, incubated on the BD BACTECTM continuous blood culture monitoring system until positive, and then PBC samples run with the Accelerate Arc system. Three Accelerate Arc instruments, and three different Accelerate Arc BC kit lots were used for each group of triplicate replicates tested per organism on each day. Two operators executed testing on alternate days. Overall, 96% of all samples tested produced a High or Low confidence ID result and no incorrect identifications were observed using the DT PLUS eDT workflow (see Table 2).
| Site | DT PLUS eDT Result | Operator 1 | Operator 2 | All Operators |
|---|---|---|---|---|
| 1 | High | 97.9% | 81.0% | 90.0% |
| Low | 0.0% | 11.9% | 5.6% | |
| No ID | 2.1% | 7.1% | 4.4% | |
| 2 | High | 83.3% | 92.9% | 87.8% |
| Low | 6.3% | 2.4% | 4.4% | |
| No ID | 10.4% | 4.8% | 7.8% | |
| 3 | High | 100% | 95.2% | 97.8% |
| Low | 0.0% | 4.8% | 2.2% | |
| No ID | 0.0% | 0.0% | 0.0% | |
| All Sites | High | 93.8% | 89.7% | 91.9% |
| Low | 2.1% | 6.3% | 4.1% | |
| No ID | 4.2% | 4.0% | 4.1% |
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b. Detection limit:
Five representative microbial species (Staphylococcus aureus, Streptococcus agalactiae, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Candida tropicalis) were used to contrive PBCs using fresh donor blood incubated in the BD BACTECTM continuous blood culture monitoring system until positive. Ten replicate samples per species were run immediately after flagging positive (at positivity) using the Accelerate Arc system. Successful reporting of accurate ID results would demonstrate that the limit of detection for samples prepared by the Accelerate Arc system was equal to at least the concentration of organisms found in a PBC sample at positivity. (Table 3) One of the Staphylococcus aureus replicate tests initially produced a no ID result but subsequently produced an accurate High Confidence ID result upon re-spotting of the same Arc-processed sample with DT and eDT workflow and re-analysis with the MBT-CA System with MBT-CA Sepsityper software extension.
Additionally, PBC samples removed at positivity were 1:10 diluted into a negative blood culture sample containing no organisms to produce a contrived sample containing a lower concentration of microorganisms. This sample dilution and preparation was performed using samples from the same five representative microbial species and a second set of 10 replicate samples per species was run using the Accelerate Arc system. The resulting samples were prepared for ID testing to demonstrate that no inaccurate ID results would be reported.
For PBCs containing bacterial organisms there is sufficient biological material at positivity for successful identification using the Accelerate Arc system followed by DT and eDT workflow and MBT-CA System with MBT-CA Sepsityper software extension analysis. For blood cultures containing yeast organisms, ID was successful after incubation of the PBC for approximately one hour (Table 3). For samples diluted 1:10, a lower concentration of microorganisms in test samples does not produce any false identifications.
Table 3: Results for Undiluted Samples. Number of High or Low confidence ID results or No ID (no identification) results for all replicate tests performed for undiluted samples. Results for bacterial organisms are shown for samples tested at positivity. i.e. 0 hour TPP (time post positive). Result for yeast shown for samples tested at 1 hour TPP.
| PBC Sample | Identification Result | |||
|---|---|---|---|---|
| Organism | TPP | High | Low | No ID |
| Staphylococcus aureus | 0 h | 8 | 1 | 1* |
| Streptococcus agalactiae | 0 h | 10 | 0 | 0 |
| Klebsiella pneumoniae | 0 h | 10 | 0 | 0 |
| Pseudomonas aeruginosa | 0 h | 10 | 0 | 0 |
| Candida tropicalis | 1 h | 9 | 1 | 0 |
*Indicates test conditions that produced an accurate High Confidence ID result upon re-spotting
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c. Sample stability:
Four representative microbial species, specifically: Klebsiella pneumonia, Staphylococcus aureus, Candida tropicalis, and Haemophilus influenzae, were used to contrive positive blood cultures using fresh donor blood incubated in the BD BACTECTM continuous blood culture monitoring system until positive. All positive blood cultures samples processed with the Accelerate Arc system were prepared for ID on the MBT-CA System with MBT-CA Sepsityper software extension using DT and eDT workflows.
Post-Positive sample stability was tested using blood culture samples incubated for extended periods of time after flagging positive: 16 hours inside the blood culture incubation system or 24 hours outside the blood culture incubation system at ambient temperature. Testing at all extended incubation conditions produced reportable and accurate results, therefore positive blood cultures can remain in the incubator up to 16 hours or be stored at ambient temperature up to 24 hours prior to Accelerate Arc system processing (Table 4). In one instance, one replicate test for Haemophilus influenzae testing at the 17.5 h condition initially produced a no ID result but subsequently produced an accurate High Confidence ID result upon re-spotting of the same Arc-processed sample with DT and eDT workflow and reanalysis with the MBT-CA System with MBT-CA Sepsityper software extension.
Table 4: Results for Post-Positive Sample Stability testing. Incubation Temperature and Incubation Time indicate conditions used for testing. Each row indicates a specific Incubation Time condition in hours and "N/A" is indicated whenever testing was performed at positivity (i.e., zero-hour time point). The results under the microbial species headers show the number of replicate tests for each condition that produced either high confidence (H => 1.80 log score), low confidence (L = 1.60-1.79 log score), or no ID (No = 1.80 log score), low confidence (L = 1.60-1.79 log score), or no ID (No