(309 days)
BK110039
Not Found
No
The summary describes a standard capillary electrophoresis instrument and its associated consumables and software for data collection and basic analysis (basecalling and sizecalling). There is no mention of AI or ML in the intended use, device description, or performance studies. The software functions described are typical for this type of analytical instrument and do not suggest the use of advanced AI/ML algorithms.
No
The device is an in vitro diagnostic device used for the detection of fluorescently-labeled human genomic DNA nucleotides by capillary electrophoresis, primarily for sequencing and fragment analysis. It is not used for treating or diagnosing a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are in vitro diagnostic devices."
No
The device description explicitly lists hardware components such as the capillary array, polymer, computer workstation, and consumables, in addition to the integrated software. This indicates it is a system that includes both hardware and software, not a software-only device.
Yes, the provided text explicitly states that the Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are in vitro diagnostic devices intended for detection of fluorescently-labeled human genomic deoxyribonucleic acid (DNA) nucleotides by capillary electrophoresis.
The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are indicated for sequencing and fragment analysis using FDA- cleared or approved assays.
Product codes
PCA
Device Description
The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are fluorescence-based DNA analysis instruments that use capillary electrophoresis technology with 8 and 24 capillaries, respectively.
The 8-capillary system and the 24-capillary system include the following components:
- 8-capillary or 24-capillary array and POP™ polymer .
- . Consumables for system qualification
- Computer workstation and monitor
- Integrated software for instrument control, data collection, quality control, . basecalling and sizecalling of samples
The following consumables (branded with the Applied Biosystems name) are required to operate the Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer.
- . 50cm Capillary Array: enable the labeled DNA fragments to migrate from the cathode toward the anode for detection
- POP-6TM Polymer: used as a separation matrix to separate DNA fragments by size ● during electrophoresis for sequencing
- POP-7TM Polymer: used as a separation matrix for separating DNA fragments by size during electrophoresis for fragment analysis
- Hi-Di™ Formamide: sample re-suspension solution used for electrokinetic ● injection and denaturing the DNA
- Sequencing Standard v1.1: used for spectral calibration of the instrument and instrument performance check
- Cathode Buffer Container: pre-filled with running buffer which maintains a source . of ions and the correct pH for electrophoresis
- Anode Buffer Container: pre-filled with running buffer which maintains a source ● of ions and the correct pH for electrophoresis
- Conditioning Reagent: pre-filled pouch used for priming the polymer pump, ● washing the pump between polymer type changes, and during instrument shutdown
- DS-30 Matrix Standard Dx: used for spectral calibration ●
- DS-33 Matrix Standard - Dx: used for spectral calibration
- DS-33 GeneScan™ Install Kit Dx: used for instrument operational qualification ●
- GeneScan™ 600 LIZ® Size Standard v2.0 Dx: used as a ladder for sizing DNA ● fragments
- Other accessories (e.g. sample plate holders, plate retainers, septa) .
Mentions image processing
Not Found
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Performance Data: Non-clinical performance of the instrument was evaluated in a reproducibility study using a representative fragment analysis assay. The reproducibility study was performed across multiple sites, using different instruments, multiple operators, and across several days. The pre-established acceptance criteria were met.
Clinical Performance Data: Clinical performance studies were conducted across 3 US clinical laboratory sites, with multiple instruments using a representative fragment analysis assay and an appropriate method comparison assay. All pre-established performance criteria were met.
Key Metrics
Not Found
Predicate Device(s)
BK110039
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.2570 Instrumentation for clinical multiplex test systems.
(a)
Identification. Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.
0
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February 21, 2020
Life Technologies Corporation Darcie Baynes Regulatory Affairs Specialist 5781 Van Allen Way Carlsbad, CA 92008
Re: K191030
Trade/Device Name: Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer Regulation Number: 21 CFR 862.2570 Regulation Name: Instrumentation For Clinical Multiplex Test Systems Regulatory Class: Class II exempt, meets the limitation of exemptions 21 CFR 862.9(a) Product Code: PCA Dated: February 3, 2020 Received: February 4, 2020
Dear Darcie Baynes:
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. 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 located 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.
Please note that if you modify your IVD in the future to exceed any of the limitations to the exemption found in 21 CFR 862.9(c), your device will require a new 510(k) prior to marketing this device in the United States and will not be exempt from the premarket notification requirements so long as it exceeds the limitations to the exemption found in 21 CFR 862.9.
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
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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).
Sincerely,
Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191030
Device Name Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer
Indications for Use (Describe)
The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are in vitro diagnostic devices intended for detection of fluorescently-labeled human genomic deoxyribonucleic acid (DNA) nucleotides by capillary electrophoresis.
The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are indicated for sequencing and fragment analysis using FDA- cleared or approved assays.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Submitter Information - 21 CFR 807.92(a)(1):
| Submitter: | Life Technologies Corporation
5781 Van Allen Way
Carlsbad, CA 92008 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Life Technologies Holdings Pte Ltd
Blk 33, #07-06, Marsiling Industrial Estate,
Road 3 Singapore 739256 |
| Establishment Registration No: | 3003673482 |
| 510(k) Number | K191030 |
| Contact: | Darcie Baynes, Sr. Regulatory Affairs
Specialist |
| Phone: | 760.918.3148 |
| Fax: | 760.603.2804 |
| E-mail: | darcie.baynes@thermofisher.com |
| Alternate Contact: | Jody Schulz, Senior Manager Regulatory
Affairs |
| Phone: | 262.357.4605 |
| Fax: | 414.278.0688 |
| E-mail: | jody.schulz@thermofisher.com |
| Date Prepared: | February 18, 2020 |
Device Name - 21 CFR 807.92(a)(2):
| Device Name: | Applied Biosystems™ 3500 Dx Genetic
Analyzer
and
Applied Biosystems™ 3500xL Dx Genetic
Analyzer |
|-----------------|---------------------------------------------------------------------------------------------------------------|
| Common Name: | DNA Genetic Analyzer |
| Classification: | Class II, exempt from the premarket
notification requirement subject to the
limitations in 21 CFR 862.9 |
| Product Code: | PCA |
4
Predicate Device 21 CFR 807.92(a)(3)
| Predicate | Applied Biosystems 3500 Dx/3500xL Dx
Genetic Analyzer CS2 and 3500 Dx Series
Software, BK110039 |
| ----------- | ------------------------------------------------------------------------------------------------------- |
|---|
Device Description 21 CFR 807.92(a)(4):
The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are fluorescence-based DNA analysis instruments that use capillary electrophoresis technology with 8 and 24 capillaries, respectively.
The 8-capillary system and the 24-capillary system include the following components:
- 8-capillary or 24-capillary array and POP™ polymer .
- . Consumables for system qualification
- Computer workstation and monitor
- Integrated software for instrument control, data collection, quality control, . basecalling and sizecalling of samples
The following consumables (branded with the Applied Biosystems name) are required to operate the Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer.
- . 50cm Capillary Array: enable the labeled DNA fragments to migrate from the cathode toward the anode for detection
- POP-6TM Polymer: used as a separation matrix to separate DNA fragments by size ● during electrophoresis for sequencing
- POP-7TM Polymer: used as a separation matrix for separating DNA fragments by size during electrophoresis for fragment analysis
- Hi-Di™ Formamide: sample re-suspension solution used for electrokinetic ● injection and denaturing the DNA
- Sequencing Standard v1.1: used for spectral calibration of the instrument and instrument performance check
- Cathode Buffer Container: pre-filled with running buffer which maintains a source . of ions and the correct pH for electrophoresis
- Anode Buffer Container: pre-filled with running buffer which maintains a source ● of ions and the correct pH for electrophoresis
- Conditioning Reagent: pre-filled pouch used for priming the polymer pump, ● washing the pump between polymer type changes, and during instrument shutdown
- DS-30 Matrix Standard Dx: used for spectral calibration ●
- DS-33 Matrix Standard - Dx: used for spectral calibration
- DS-33 GeneScan™ Install Kit Dx: used for instrument operational qualification ●
- GeneScan™ 600 LIZ® Size Standard v2.0 Dx: used as a ladder for sizing DNA ● fragments
- Other accessories (e.g. sample plate holders, plate retainers, septa) .
5
Intended Use 21 CFR 807.95(a)(5):
The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are in vitro diagnostic devices intended for detection of fluorescently-labeled human genomic deoxyribonucleic acid (DNA) nucleotides by capillary electrophoresis.
The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are indicated for sequencing and fragment analysis using FDA- cleared or approved assays.
Predicate Device Comparison 21 CFR 807.92(a)(6):
A summary of the technological characteristics of the device compared to the predicate device is provided. The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer and the legally marketed device the Applied Biosystems 3500 Dx/3500xL Dx Genetic Analyzer CS2 and 3500 Dx Series Software are compared in the table below.
| Feature | Applied
Biosystems 3500
Dx/3500xL Dx CS2
and 3500 Dx Series
Software
(BK110039) | Applied
Biosystems™ 3500
Dx Genetic
Analyzer and the
Applied
Biosystems™
3500xL Dx Genetic
Analyzer (with
Fragment
Analysis) | Comparison |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| 510k number | BK110039 | K191030 | N/A |
| Regulation | 862.2570 | 862.2570 | Same |
| Product Code | PCA | PCA | Same |
| Device Class | Class II | Class II | Same |
| Intended Use | The Applied
Biosystems® 3500
Dx / 3500xL Dx
Genetic Analyzer
CS2 and 3500 Dx
Series Software are
in vitro diagnostic
devices intended for
the sequencing
(detection and
identification) of
fluorescently-
labeled
deoxyribonucleic | The Applied
Biosystems™ 3500
Dx Genetic
Analyzer and the
Applied
Biosystems™
3500xL Dx Genetic
Analyzer are in vitro
diagnostic devices
intended for
detection of
fluorescently-
labeled human
genomic | Software upgrade to
Data Collection
Software (DCS) 3
IVD v3.2 and
enablement of
Fragment Analysis
in Diagnostic mode. |
| Feature | Applied
Biosystems 3500
Dx/3500xL Dx CS2
and 3500 Dx Series
Software
(BK110039) | Applied
Biosystems™ 3500
Dx Genetic
Analyzer and the
Applied
Biosystems™
3500xL Dx Genetic
Analyzer (with
Fragment
Analysis) | Comparison |
| | acid (DNA) by
capillary
electrophoresis.
The Applied
Biosystems® 3500
Dx / 3500xL Dx
Genetic Analyzer
CS2 with 3500 Dx
Series Software
2011 (v1) are
indicated for use
with FDA-cleared
or approved
sequencing assays
specifying their use
and only by
technologists
trained in laboratory
techniques,
procedures, and use
of the analyzer. | deoxyribonucleic
acid (DNA)
nucleotides by
capillary
electrophoresis.
The Applied
Biosystems™ 3500
Dx Genetic
Analyzer and the
Applied
Biosystems™
3500xL Dx Genetic
Analyzer are
indicated for
sequencing and
fragment analysis
using FDA- cleared
or approved assays. | |
| Data Collection
Software | 3500 Dx Data
Collection Software
2011 v1.01 | Applied
Biosystems™ 3500
Dx Series Data
Collection Software
3 IVD v3.2 | Upgrade to Data
Collection Software
3 IVD v3.2 |
| Firmware | 6228001-05 | 6228001-05 | Same |
| Computer | Dell OptiPlex XE | Dell OptiPlex XE2 | Upgrade to new
model. |
| Windows | Windows® 7 | Windows® 7 | Same |
| Laser | Single-line 505 nm,
solid-state | Single-line 505 nm,
solid-state | Same |
| Feature | Applied
Biosystems 3500
Dx/3500xL Dx CS2
and 3500 Dx Series
Software
(BK110039) | Applied
Biosystems™ 3500
Dx Genetic
Analyzer and the
Applied
Biosystems™
3500xL Dx Genetic
Analyzer (with
Fragment
Analysis) | Comparison |
| Electrophoresis
Voltage | Up to 20Kv | Up to 20Kv | Same |
| Oven Temperature | 18°C to 70°C | 18°C to 70°C | Same |
| Operating
Environment | Temperature: 15°C-
30°C | Temperature: 15°C-
30°C | Same |
| | Humidity: 20-80%
(non-condensing) | Humidity: 20-80%
(non-condensing) | Same |
| Main Power
Voltage | 100-240 V ±10%;
50–60 Hz | 100–240 V ±10%;
50–60 Hz | Same |
| Power
Consumption | 320 VA | 320VA | Same |
| Dimensions
(Width x Depth x
Height) | 61cm(122cm) x
61cm x 72cm | 61cm(122cm) x
61cm x 72cm | Same |
| Weight | 82Kg | 82Kg | Same |
| Polymer Use | POP-6TM Dx | POP-6TM Dx and
POP-7TM Dx | Inclusion of POP-7
for Fragment
Analysis application
in IVD mode of
proposed device. |
| Capillary Array | 50 cm length
available in 8-
capillary and 24
capillary
configuration | 50 cm length
available in 8-
capillary and 24
capillary
configuration | Same, however the
50 cm array will be
used for fragment
analysis workflow
in IVD mode. |
| Applications | Sequencing and
Fragment Analysis
in RUO mode,
Sequencing in IVD
mode | Sequencing and
Fragment Analysis
in RUO mode,
Sequencing and
Fragment Analysis
in IVD mode | Inclusion of
Fragment Analysis
application in IVD
mode of proposed
device. |
| Feature | Applied
Biosystems 3500
Dx/3500xL Dx CS2
and 3500 Dx Series
Software
(BK110039) | Applied
Biosystems™ 3500
Dx Genetic
Analyzer and the
Applied
Biosystems™
3500xL Dx Genetic
Analyzer (with
Fragment
Analysis) | Comparison |
| Input Sample | DNA | DNA | Same |
6
7
8
9
Non-Clinical Performance Data 21 CFR 807.92(b)(1)
Non-clinical performance of the instrument was evaluated in a reproducibility study using a representative fragment analysis assay. The reproducibility study was performed across multiple sites, using different instruments, multiple operators, and across several days. The pre-established acceptance criteria were met.
Clinical Performance Data 21 CFR 807.92(b)(2)
Clinical performance studies were conducted across 3 US clinical laboratory sites, with multiple instruments using a representative fragment analysis assay and an appropriate method comparison assay. All pre-established performance criteria were met.
Conclusion 21 CFR 807.92(b)(3)
The proposed Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer with fragment analysis and sequencing, and the legally marketed Applied Biosystems 3500 Dx/3500xL Dx Genetic Analyzer and 3500 Dx Series Data Collection Software with sequencing use the same capillary electrophoresis technology and are the same instrument. The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer did not require changes to the instrument hardware or firmware to expand the intended use to include fragment analysis. The change was made in the Applied Biosystems™ 3500 Dx Series Data Collection Software to enable the fragment analysis workflow in the Diagnostic mode.
Therefore, the Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer and the legally marketed device, the Applied Biosystems 3500 Dx/3500xL Dx Genetic Analyzer CS2 and 3500 Dx Series Software. are substantially equivalent based on the study data provided in this 510(k). In addition, the performance of the fragment analysis application has been demonstrated by Clinical and Non-Clinical performance studies using a representative assay.