(77 days)
Not Found
No
The description focuses on standard PCR technology and data analysis, with no mention of AI or ML algorithms.
No
The device is intended for in vitro diagnostic use to detect nucleic acid sequences, not for direct therapeutic treatment of patients.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use."
No
The device description explicitly lists hardware components such as the instrument, thermal block, computer workstation, and calibration materials, in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The statement explicitly says the instrument is "intended for in vitro diagnostic use". It also specifies that it's used to detect nucleic acid sequences in "human-derived specimens" and in combination with "nucleic acid reagent kits/tests manufactured and labeled for diagnostic purposes".
- Device Description: The description details a system designed to perform fluorescence-based PCR for the "detection of target nucleic acid sequences" using real-time analysis, which is a common technique in diagnostic testing.
- Performance Studies: The document includes detailed descriptions of both non-clinical (analytical performance, precision, reproducibility, detection limit) and clinical performance studies (comparison studies with a predicate device and enhanced toxigenic culture). These types of studies are required for IVD devices to demonstrate their accuracy and reliability for diagnostic purposes.
- Key Metrics: The inclusion of sensitivity and specificity values from the clinical studies further confirms its intended use in diagnosis.
- Predicate Device: The mention of a predicate device (Abbott m2000™ System) which is also an IVD system, indicates that this device is being compared to existing diagnostic technology.
All of these points strongly indicate that the QuantStudio™ Dx Real-Time PCR Instrument with QuantStudio™ Dx Software is intended and used for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The QuantStudio™ Dx Real-Time PCR Instrument with QuantStudio™ Dx Software is intended to perform fluorescence-based PCR to provide detection of FDA cleared and approved nucleic acid sequences in human-derived specimens. The QuantStudio™ Dx Real-Time PCR Instrument with QuantStudio™ Dx Software is intended for in vitro diagnostic use by trained laboratory technologists in combination with nucleic acid reagent kits/tests manufactured and labeled for diagnostic purposes on this instrument.
Product codes
OOI
Device Description
The QuantStudio™ Dx Real-Time PCR Instrument is a bench top Real-Time PCR instrument that uses fluorescent-based polymerase chain reaction (PCR) reagents to provide qualitative or quantitative detection of target nucleic acid sequences (targets) using real-time analysis.
The QuantStudio™ Dx Real-Time PCR Instrument system includes the following components:
- QuantStudio™ Dx Real-Time PCR instrument with embedded graphical user . interface (eGUI) Touchscreen
- Thermal Block, also referred to as the sample block, with associated Heated Cover . and Plate Adaptor
- Calibration and verification materials for instrument qualification .
- . Computer workstation with a monitor, keyboard and mouse
- QuantStudio™ Dx instrument software .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human-derived specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained laboratory technologists / in vitro diagnostic use
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
Description of the test set: For the Precision/Within Laboratory Repeatability study, a blinded fourmember panel consisting of C. difficile positive and negative sample. For Reproducibility, a blinded and randomized study panel containing Clostridium difficile negative and positive samples. For Detection limit, quantified (CFU/mL) cultures of two C. difficile strains (ATCC BAA-1870 and ATCC BAA-1872) serially diluted in a negative fecal matrix. For Clinical Performance, 792 samples collected from patients suspected of having Clostridium difficile-associated disease (CDAD).
Sample size: Precision/Within Laboratory Repeatability study - a blinded fourmember panel; Reproducibility - panel and assay controls for five (5) days in triplicate for each instrument, resulting in 90 total results for each panel member; Detection limit – serial dilutions to determine 95% positivity; Clinical Performance - 792 samples (788 for Cytotoxin comparison, 791 for Enhanced Toxigenic Culture comparison).
Data source: For Precision/Within Laboratory Repeatability study, C. difficile positive and negative samples. For Reproducibility, Clostridium difficile negative and positive samples. For Detection limit, quantified (CFU/mL) cultures of two C. difficile strains (ATCC BAA-1870 and ATCC BAA-1872) in a negative fecal matrix. For Clinical Performance, human-derived specimens from patients suspected of having Clostridium difficile-associated disease (CDAD) at four (4) distinct geographical sites across the United States.
Annotation protocol: Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study type: Non-clinical performance data (Analytical performance: Precision/Reproducibility, Detection limit) and Clinical performance data (Comparison studies: Method comparison with predicate device - Tissue Culture Cytotoxicity Assay Comparison, Enhanced Toxigenic Culture Comparison).
Sample size: Precision/Reproducibility: blinded four-member panel (Precision), reproducibility panel and assay controls (Reproducibility). Detection limit: two C. difficile strains (ATCC BAA-1870 and ATCC BAA-1872) serially diluted. Clinical performance: 792 samples, 788 for Tissue Culture Cytotoxicity Assay, 791 for Enhanced Toxigenic Culture.
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key results:
Precision/Reproducibility:
Precision: For C. difficile 5X LoD, 100% Detection, Average Ct 16.51, STDEV 0.42, %CV 2.6%. For 2X LoD, 100% Detection, Average Ct 17.70, STDEV 0.76, %CV 4.3%. For 0.3X LoD, 88% Detection, Average Ct 21.13, STDEV 1.37, %CV 6.5%. Negative samples 0% Detection.
Reproducibility: Low Positive 2x LoD, 90/90 detection across all sites. Med Positive 5x LoD, 90/90 detection across all sites. Negative Specimen and Negative Control 0/90 detection. Positive Control 90/90 detection.
Detection limit: Final assay LoD is 4.2E-01 CFU/assay for C. difficile.
Tissue Culture Cytotoxicity Assay Comparison: Sensitivity 93.3% (95% CI: 86.9%-96.7%), Specificity 93.4% (95% CI: 91.3%-95.0%).
Enhanced Toxigenic Culture Comparison: Sensitivity 87.3% (95% CI: 81.1%-91.6%), Specificity 98.7% (95% CI: 97.5%-99.4%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision/Reproducibility: % Detection, Average Ct, STDEV, %CV.
Detection limit: Lowest concentration at which 95% of all replicates tested positive.
Tissue Culture Cytotoxicity Assay Comparison: Sensitivity 93.3%, Specificity 93.4%.
Enhanced Toxigenic Culture Comparison: Sensitivity 87.3%, Specificity 98.7%.
Predicate Device(s)
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
MAR 0 8 2013
510(k) Summary
Summary of Safety and Effectiveness
Submitter Information - 21 CFR 807.92(a)(1):
- Life Technologies Corporation Submitter: 5791 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
- Contact: Deanna Vella, Regulatory Affairs Manager
Phone: 760-918-3000
760-476-6934 Fax:
E-mail: deanna.vella@lifetech.com
Alternate Contact: Nikki Arora, Engineer, Regulatory Affairs
Phone: 650-554-2268
Fax: 650-638-6786
nikki.arora@lifetech.com E-mail:
Date Prepared: December 20, 2012
Name of Device and Classification - 21 CFR 807.92(a)(2):
QuantStudio™ Dx Real-Time PCR Instrument Product Name:
Device Classification: Class II
Product Code: OOI, Real-Time Nucleic Acid Amplification System for Real Time Instruments.
1
ذابة ( ) - ) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Predicate: Abbott m2000™ System consisting of m2000sp and m2000rt instruments, K092705
Device Description - 21 CFR 807.92(a)(4):
The QuantStudio™ Dx Real-Time PCR Instrument is a bench top Real-Time PCR instrument that uses fluorescent-based polymerase chain reaction (PCR) reagents to provide qualitative or quantitative detection of target nucleic acid sequences (targets) using real-time analysis.
The QuantStudio™ Dx Real-Time PCR Instrument system includes the following components:
- QuantStudio™ Dx Real-Time PCR instrument with embedded graphical user . interface (eGUI) Touchscreen
- Thermal Block, also referred to as the sample block, with associated Heated Cover . and Plate Adaptor
- Calibration and verification materials for instrument qualification .
- . Computer workstation with a monitor, keyboard and mouse
- QuantStudio™ Dx instrument software .
Intended Use/Indications for Use - 21 CFR 807.92(a)(5):
The QuantStudio™ Dx Real-Time PCR Instrument with QuantStudio™ Dx Software is intended to perform fluorescence-based PCR to provide detection of FDA cleared and approved nucleic acid sequences in human-derived specimens. The QuantStudio™ Dx Real-Time PCR Instrument with QuantStudio™ Dx Software is intended for in vitro diagnostic use by trained laboratory technologists in combination with nucleic acid reagent kits/tests manufactured and labeled for diagnostic purposes on this instrument.
Summary of technological characteristics of the device compared to the predicate devices- 21 CFR 807.92(a)(6):
The Life Technologies QuantStudio™ Dx Real-Time PCR Instrument ("Subject Device") and the legally marketed devices, Abbott m2000™ System ("Predicate Device") is described in the table below:
2
Predicates Comparison – Life Technologies QuantStudio™ Dx Real-Time PCR
Instrument vs. Abbott m2000™ System
| Item | Subject Device
QuantStudio™ Dx
Real-Time PCR
Instrument | Predicate Device
Abbott m2000™ System | |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Similarities | | | |
| 510(k) | N/A | K092705 | |
| Regulation | 862.2570
Instrumentation for
clinical multiplex test
systems. | Same | |
| Product Code | OOI: Real-Time
Nucleic Acid
Amplification System
for Real Time
Instruments. | OOI: Real-Time Nucleic
Acid Amplification
System for Real Time
Instruments. | |
| Device Class | Class II | Same | |
| Intended Use | The QuantStudio™ Dx Real-Time PCR
Instrument with
QuantStudio™ Dx
Software is intended to
perform fluorescence-
based PCR to provide
detection of FDA
cleared and approved
nucleic acid sequences
in human-derived
specimens. The
QuantStudio™ Dx
Real-Time PCR
Instrument with
QuantStudio™ Dx
Software is intended
for in vitro diagnostic
use by trained
laboratory
technologists in
combination with
nucleic acid reagent
kits/tests manufactured
and labeled for
diagnostic purposes on | The Abbott m2000™
System is intended for in
vitro diagnostic use in
performing FDA cleared
and approved nucleic acid
testing in clinical
laboratories. It comprises
the Abbott m2000sp and
the Abbott m2000rt
instruments. The Abbott
m2000sp is an automated
system for performing
sample preparation for
nucleic acid testing. The
Abbott m2000rt is an
automated system for
performing fluorescence-
based PCR to provide
quantitative and qualitative
detection of nucleic acid
sequences. | |
| Item | Subject Device
QuantStudio™ Dx
Real-Time PCR
Instrument | Predicate Device
Abbott m2000™ System | |
| Similarities | | | |
| | this instrument. | | |
| Technology/
Detection | Real-Time PCR | Same | |
| | Specimen Types | Nucleic acid | Same |
| Assay Format | Homogeneous, closed
tube PCR | Same | |
| Degree of
Automation | Requires manual
transfer of
amplification mixture
to
amplification/detection
instrument.
Automated control of
amplification,
detection, and data
analysis. | Same | |
| Primary
Operational
Amplification
and Detection
Components | Integrated thermal
cycler and
microvolume
fluorimeter for walk
away PCR
amplification and
detection | Same | |
| | Heating Method
for Amplification | Peltier device with
sample block | Same |
| Detection
Procedure | Optical detection of
stimulated
fluorescence | Same | |
| Detection
Chemistries | Fluorescence labeled
target-specific probes | Same | |
| Item | Subject Device
QuantStudioTM Dx Real-Time PCR Instrument | Predicate Device
Abbott m2000TM System | |
| Differences | | | |
| Product Code | OOI: Real-Time Nucleic Acid Amplification System for Real Time Instruments. | OOI: Real-Time Nucleic Acid Amplification System for Real Time Instruments. | |
| User Interface | PC with instrument-specific software. Instrument has touchscreen console. | PC with instrument-specific software | |
| Amplification Reaction Volume | 10-30 $\mu$ L in 96-well Fast PCR plates | 25-100 $\mu$ L in 96-well PCR plates | |
| Sample Preparation | No automated sample processing instrument offered in conjunction with the QuantStudioTM Dx Instrument. | Pairing with the m2000sp instrument provides automated sample processing. | |
・
·
:
.
3
and the control control control of the control of the control of
and the state of the state
4
Our analysis of the differences in user interface, amplification reaction volumes, and sample preparation between the Subject Device and the Predicate Device indicates that these differences do not impact performance or raise new/different questions of safety and effectiveness, and therefore render the Subject Device as Substantially Equivalent.
Special Control/Guidance Document Referenced (if applicable):
Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocum ents/ucm077819.htm
Performance Data - 21 CFR 807.92(b):
As noted in the Cover Letter in this 510(k), Quidel® Corporation will submit a traditional 510(k) for the Molecular Real-Time PCR Direct C. Difficile Tox A/B that will be used with the QuantStudio™ Dx Real-Time PCR Instrument. To that end, testing to demonstrate non-clinical performance of the OuantStudio™ Dx Real-Time PCR Instrument was led by Quidel® Corporation as part of a collaboration agreement between
5
the two companies. This section provides a brief summary of the non-clinical performance studies and conclusions that demonstrate instrument performance when testing the Quidel Molecular Real-Time PCR Direct C. Difficile Tox A/B..
Complete non-clinical performance data can be found in Quidel's Molecular Real-Time PCR Direct C. Difficile Tox A/B traditional 510(k) submission.
Non-Clinical Performance Data- 21 CFR 807.92(b)(1):
Analytical performance:
Precision/Reproducibility: a.
Precision: For the Precision/Within Laboratory Repeatability study, a blinded fourmember panel consisting of C. difficile positive and negative sample was tested by two operators, twice a day using a single assay lot of Quidel Molecular Direct C. difficile Assay for twelve (12) days.
| QuantStudio™ Dx Real-Time PCR Instrument | ||||
|---|---|---|---|---|
| C. difficile | 5X LoD | 2X LoD | 0.3X LoD | Negative |
| % Detection | 100% | 100% | 88% | 0% |
| Average Ct | 16.51 | 17.70 | 21.13 | N/A |
| STDEV | 0.42 | 0.76 | 1.37 | N/A |
| %CV | 2.6% | 4.3% | 6.5% | N/A |
Reproducibility: In order to confirm the reproducibility of the Quidel Molecular Direct C. difficile Assay a blinded and randomized study panel containing Clostridium difficile negative and positive samples were tested at three (3) test sites, two of which were clinical sites. Each site tested a reproducibility panel and assay controls for five (5) days in triplicate on each instrument. The testing was done by two operators at each site. Each operator ran the panel once a day using one lot of Quidel Molecular Direct C. difficile Assay.
6
| Reproducibility Results – QuantStudio™ Dx Instrument | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Panel | ||||||||||
| Member | ||||||||||
| ID | Site 1 | Site 2 | Site 3 | Total | ||||||
| Results | ||||||||||
| Results | AVE | |||||||||
| Ct | %CV | Results | AVE | |||||||
| Ct | %CV | Results | AVE | |||||||
| Ct | %CV | |||||||||
| High | ||||||||||
| Negative | ||||||||||
| 0.3x LoD | 8/30 | 22.9 | 5.0 | 15/30 | 22.5 | 1.3 | 15/30 | 22.5 | 1.5 | 38/90 |
| Low | ||||||||||
| Positive | ||||||||||
| 2x LoD | 30/30 | 20.4 | 5.9 | 30/30 | 19.0 | 5.1 | 30/30 | 19.2 | 0.8 | 90/90 |
| Med | ||||||||||
| Positive | ||||||||||
| 5x LoD | 30/30 | 18.4 | 4.2 | 30/30 | 17.5 | 0.4 | 30/30 | 17.9 | 0.7 | 90/90 |
| Negative | ||||||||||
| Specimen | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 |
| Negative | ||||||||||
| Control | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 |
| Positive | ||||||||||
| Control | 30/30 | 15.7 | 0.6 | 30/30 | 15.7 | 0.1 | 30/30 | 15.5 | 0.1 | 90/90 |
b. Detection limit:
The analytical sensitivity (limit of detection or LoD) of the Quidel Molecular Direct C. difficile Assay was determined on QuantStudio™ Dx instrument using quantified (CFU/mL) cultures of two C. difficile strains (ATCC BAA-1870 and ATCC BAA-1872) serially diluted in a negative fecal matrix. Analytical sensitivity (LoD) is defined as the lowest concentration at which 95% of all replicates tested positive.
| Instrument | Strain | |
|---|---|---|
| ATCC BAA-1870 LoD | ||
| (CFU per assay) | ATCC BAA-1872 LoD | |
| (CFU per assay) | ||
| QuantStudio™ | ||
| Dx | 4.2 E-01 | 4.0E-02 |
The final assay LoD is defined as the higher of the two strain concentrations where 95% positivity was observed. The final assay LoD is 4.2E-01 CFU/assay.
7
Clinical Performance Data- 21 CFR 807.92(b)(2):
Comparison studies:
Method comparison with predicate device: a.
Performance characteristics of the Quidel Molecular Direct C. difficile Assay were established during a prospective study conducted August to November 2012. Seven hundred and ninety-two (792) samples used for this study were collected from patients suspected of having Clostridium difficile-associated disease (CDAD) at four (4) distinct geographical sites across the United States. These specimens were tested with the Quidel Assay on the Life Technologies QuantStudio™ Dx Real-Time PCR Instrument at one of three (3) facilities.
| Combined Sites – Age and Gender Distribution | ||||
|---|---|---|---|---|
| Age | Gender | Total prevalence of the | ||
| Quidel Molecular | ||||
| Direct C. difficile | ||||
| Assay on the | ||||
| QuantStudioTM Dx | ||||
| Real-Time PCR | ||||
| Instrument | ||||
| Male | Female | Total | ||
| Unknown | 2 | 50% (1/2) | ||
| ≤ 2 years | 5 | 5 | 10 | 10% (1/10) |
| 2 to 21 to 59 years | 158 | 170 | 328 | 18% (60/328) |
| ≥ 60 years | 163 | 203 | 366 | 18% (65/366) |
| Total | 370 | 420 | 792 | 18% (145/792) |
Patient age and gender for the combined sites are presented below.
- includes two (2) patient samples with unknown age and gender.
Tissue Culture Cytotoxicity Assay Comparison
Seven hundred and ninety-two (792) samples were tested by both the Quidel Molecular Direct C. difficile Assay and the tissue culture cytotoxin assay. Three (3) specimens (0.4%) were indeterminate in the cytotoxin assay due to toxicity in the antitoxin well. One (1) specimen (0.1%) was invalid in the Quidel Molecular Direct C. difficile Assay
8
when initially tested. The specimen yielded a valid result (it was negative) when retested according to the Quidel Molecular Direct C. difficile Assay draft instructions for use. We elected to calculate clinical performance based on the initial test result obtained for each specimen. Therefore, the data below is for the remaining seven hundred and eighty-eight (788) specimens.
| Combined Sites – Combined Ages | ||||||||
|---|---|---|---|---|---|---|---|---|
| Tissue Culture Cytotoxin | 95% CI | |||||||
| POS | NEG | Total | Sensitivity | |||||
| Quidel | ||||||||
| Molecular | ||||||||
| Real- | ||||||||
| Time | ||||||||
| PCR | ||||||||
| Direct C. | ||||||||
| difficile | ||||||||
| Tox A/B | ||||||||
| Assay | POS | 98 | 45* | 143 | 93.3% | 86.9% | 96.7% | |
| NEG | 7** | 638 | 645 | Specificity | 93.4% | 91.3% | 95.0% | |
| Total | 105 | 683 | 788 |
- Of the forty-five (45) discordant specimens (Quidel Molecular Positive/Tissue Culture Cytotoxin Negative) reported, forty-four (44) were tested with a FDA-cleared molecular device. Thirty-five (35) of these specimens were positive for C. difficile, and nine (9) were negative. The remaining specimen was unavailable for testing.
**Seven (7) discordant specimens (Quidel Negative/Tissue Culture Cytotoxin Positive) reported were tested with a FDA-cleared molecular device. Two (2) of these specimens were found positive for C. difficile, and five (5) were negative.
9
Enhanced Toxigenic Culture Comparison
Seven hundred and ninety-two (792) samples were tested by both the Ouidel Molecular Direct C. difficile Assay and enhanced toxigenic culture. One (1) specimen (0.1%) was invalid in the Quidel Molecular Direct C. difficile Assay when initially tested. The specimen yielded a valid result (it was negative) when retested according to the Quidel Molecular Direct C. difficile Assay draft instructions for use. We elected to calculate clinical performance based on the initial test result obtained for each specimen. Therefore, the data below is for the remaining seven hundred and nimety-one (791) specimens.
| Combined Sites – Combined Ages | ||||||||
|---|---|---|---|---|---|---|---|---|
| Enhanced Toxigenic Culture | 95% CI | |||||||
| POS | NEG | Total | Sensitivity | 87.3% | 81.1% | 91.6% | ||
| Quidel | ||||||||
| Molecular | ||||||||
| Direct C. | ||||||||
| difficile | ||||||||
| Assay | POS | 137 | 8* | 145 | Specificity | 98.7% | 97.5% | 99.4% |
| NEG | 20** | 626 | 646 | |||||
| Total | 157 | 634 | 791 |
- Eight (8) discordant specimens (Quidel Molecular Positive/Enhanced Toxigenic Culture Negative) reported were tested with a FDA-cleared molecular device. Two (2) of these specimens were positive for C. difficile, and six (6) were negative.
** Seventeen (17) out of twenty (20) discordant specimens (Quidel Negative/ Enhanced Toxigenic Culture Positive) reported, were tested with a FDA-cleared molecular device. Three (3) specimens were unavailable for testing. Eleven (11) of these specimens were found negative for C. difficile, and six (6) were positive.
Conclusion
This summary of safety and effectiveness information provides the necessary detail for a determination of substantial equivalence for the QuantStudio™ Dx Real-Time PCR Instrument.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 8, 2013
Life Technologies Deanna Vella 5791 Van Allen Way Carlsbad, California 92008
Re: K123955
Trade/Device Name: Life Technologies Regulation Number: 21 CFR §862.2570 Regulation Name: QuantStudio™ DX Real-Time PCR Instrument Regulatory Class: Class II Product Code: OOI Dated: December 20, 2012 Received: December 21, 2012
Dear Ms. Vella:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may; therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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.
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); medical device reporting (reporting of medical
11
Page 2 - Ms. Vella
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807:97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours,
Uwerschierf -S for
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
12
Indications for Use Statement
510(k) Number (if known): K123955
Device Name: QuantStudio™ Dx Real-Time PCR Instrument
Indications for Use:
The QuantStudio™ Dx Real-Time PCR Instrument with QuantStudio™ Dx Software is intended to perform fluorescence-based PCR to provide detection of FDA cleared and approved nucleic acid sequences in human-derived specimens. The QuantStudio™ Dx Real-Time PCR Instrument with QuantStudio™ Dx Software is intended for in vitro diagnostic use by trained laboratory technologists in combination with nucleic acid reagent kits/tests manufactured and labeled for diagnostic purposes on this instrument.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Center for Devices and Radiological Health
Raquel Aृङ्घिeat -- 3
2013.03.03.07 -05.00 -05.00'
Division Sign-Off CDRH, Center for Devices and Radiological Health
510(k) K123955
Page 1 of 1_