(77 days)
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.
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 .
Here's an analysis of the provided text to extract information about the acceptance criteria and the study demonstrating the device meets them:
K123955: QuantStudio™ Dx Real-Time PCR Instrument
This submission concerns the QuantStudio™ Dx Real-Time PCR Instrument, which is a benchtop real-time PCR instrument intended for in vitro diagnostic use to detect FDA-cleared and approved nucleic acid sequences in human-derived specimens. The performance data presented focuses on its use with the Quidel® Molecular Real-Time PCR Direct C. difficile Tox A/B Assay.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the "Precision/Reproducibility" and "Detection Limit" sections, and then more explicitly in the "Comparison Studies" section through performance metrics like sensitivity and specificity against a reference method (Tissue Culture Cytotoxicity Assay and Enhanced Toxigenic Culture).
Implicit Acceptance Criteria (Analytical Performance):
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (QuantStudio™ Dx with Quidel C. difficile Assay) |
|---|---|---|
| Precision (Within-Lab Repeatability) | Consistent detection rates across different LoD levels and operators; low %CV for Ct values. (Generally, 100% detection for 2X LoD and above, and high detection for 0.3X LoD) | 5X LoD: 100% Detection, Avg Ct: 16.51, STDEV: 0.42, %CV: 2.6% 2X LoD: 100% Detection, Avg Ct: 17.70, STDEV: 0.76, %CV: 4.3% 0.3X LoD: 88% Detection, Avg Ct: 21.13, STDEV: 1.37, %CV: 6.5% Negative: 0% Detection |
| Reproducibility (Multi-Site) | Consistent detection rates and low %CV for Ct values across multiple sites, operators, and days. (Generally, 100% detection for 2X LoD and above, and high detection for 0.3X LoD) | High Negative 0.3x LoD: 38/90 positive across 3 sites (individual site results: 8/30, 15/30, 15/30); AVE Ct %CV range: 1.3-5.0 Low Positive 2x LoD: 90/90 positive across 3 sites; AVE Ct %CV range: 0.8-5.9 Med Positive 5x LoD: 90/90 positive across 3 sites; AVE Ct %CV range: 0.4-4.2 Negative Specimen: 0/90 positive Negative Control: 0/90 positive Positive Control: 90/90 positive; AVE Ct %CV range: 0.1-0.6 |
| Detection Limit (LoD) | Defined as the lowest concentration at which 95% of all replicates tested positive. | Final assay LoD: 4.2E-01 CFU/assay (based on ATCC BAA-1870 and ATCC BAA-1872 strains, where 95% positivity was observed) |
Explicit Acceptance Criteria (Clinical Performance against Reference Method):
| Performance Metric | Acceptance Criteria (Implicit - based on comparison study to predicate/reference) | Reported Device Performance (QuantStudio™ Dx with Quidel C. difficile Assay) |
|---|---|---|
| Sensitivity (vs. Tissue Culture Cytotoxicity Assay) | High sensitivity (specific numerical target not provided, but typically >90% for diagnostic assays) | 93.3% (95% CI: 86.9% - 96.7%) |
| Specificity (vs. Tissue Culture Cytotoxicity Assay) | High specificity (specific numerical target not provided, but typically >90% for diagnostic assays) | 93.4% (95% CI: 91.3% - 95.0%) |
| Sensitivity (vs. Enhanced Toxigenic Culture) | High sensitivity | 87.3% (95% CI: 81.1% - 91.6%) |
| Specificity (vs. Enhanced Toxigenic Culture) | High specificity | 98.7% (95% CI: 97.5% - 99.4%) |
2. Sample Size and Data Provenance for the Test Set
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Analytical Test Set (Precision/Reproducibility):
- Precision: A "blinded four-member panel consisting of C. difficile positive and negative sample" tested over 12 days by 2 operators, twice a day, using a single assay lot. The total number of tests for each panel member would be 48 (2 operators * 2 times/day * 12 days). For example, 0.3x LoD shows 88% detection, implying 42 positive results out of 48 total tests.
- Reproducibility: A "blinded and randomized study panel" tested at three (3) test sites. Each site tested the panel for five (5) days in triplicate on each instrument, by two operators. Each operator ran the panel once a day. This means for each panel member, at each site, there were 30 tests (2 operators * 5 days * 3 replicates). Total tests for each panel member across all three sites would be 90 (30 tests/site * 3 sites).
- Data Provenance: Not explicitly stated for analytical studies, but given the manufacturer's location and the mention of Quidel, it's likely primarily US-based or an international corporate R&D setting. The study is prospective in nature, designed specifically for this validation.
-
Clinical Test Set (Comparison Studies):
- Sample Size: 792 samples initially collected. 788 specimens were used for the Tissue Culture Cytotoxicity Assay comparison, and 791 specimens were used for the Enhanced Toxigenic Culture comparison (due to removed invalid/indeterminate results).
- Data Provenance: Prospective study conducted from August to November 2012. Samples were "collected from patients suspected of having Clostridium difficile-associated disease (CDAD) at four (4) distinct geographical sites across the United States."
3. Number of Experts and Qualifications for Ground Truth
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Analytical Studies: Ground truth for analytical studies (precision, reproducibility, LoD) is typically based on known concentrations of the target analyte (like C. difficile strains in CFU/mL) prepared in a laboratory setting. No external "experts" are typically involved in establishing this ground truth beyond the scientific personnel designing and executing the standard preparations and dilutions.
-
Clinical Studies:
- Tissue Culture Cytotoxicity Assay: This is a laboratory-based reference method for detecting C. difficile toxin. The "experts" involved would be the laboratory personnel performing and interpreting this gold standard assay. Their qualifications are not specified but would typically involve trained medical technologists or microbiologists.
- Enhanced Toxigenic Culture: This is another laboratory-based reference method. Similar to the cytotoxicity assay, the "experts" would be trained laboratory personnel. Their qualifications are not specified.
- The document does not mention a panel of experts for consensus reading of raw data or images. The ground truth relies on established laboratory methodologies.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method involving multiple human readers for the test set.
- For the analytical studies, results are based on direct output from the instrument (detection yes/no, Ct values) against predetermined concentrations, so no adjudication is required.
- For the clinical comparison studies, the "ground truth" (reference standard) is provided by the Tissue Culture Cytotoxicity Assay and Enhanced Toxigenic Culture. Discordant results between the Quidel Molecular Direct C. difficile Assay on the QuantStudio™ Dx and these reference methods were further investigated by testing with an "FDA-cleared molecular device." This serves as a form of secondary adjudication or reconciliation for discordant results but does not involve human readers adjudicating an algorithm's output. For example:
- For the Cytotoxicity comparison, 45 Quidel Positive/Tissue Culture Negative were re-tested with an FDA-cleared molecular device: 35 positive, 9 negative.
- 7 Quidel Negative/Tissue Culture Positive were re-tested with an FDA-cleared molecular device: 2 positive, 5 negative.
- Similar reconciliation was done for the Enhanced Toxigenic Culture comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the standalone performance of the instrument with a specific diagnostic assay, and its concordance with established reference laboratory methods. There is no mention of human readers evaluating cases with and without AI assistance.
6. Standalone (Algorithm Only) Performance
Yes, the studies presented demonstrate standalone performance of the QuantStudio™ Dx Real-Time PCR Instrument (in conjunction with the Quidel Molecular Direct C. difficile Assay). The data provided (detection rates, Ct values, sensitivity, specificity) represent the performance of the instrument/assay system without direct human-in-the-loop intervention for result interpretation beyond running the assay and reviewing its output.
7. Type of Ground Truth Used
- Analytical Studies (Precision, Reproducibility, LoD): Known concentrations of specific C. difficile strains (e.g., ATCC BAA-1870 and ATCC BAA-1872) diluted in a negative fecal matrix. This is a form of analytical (spiked) ground truth.
- Clinical Studies (Comparison Studies):
- Tissue Culture Cytotoxicity Assay: An established laboratory method for detecting C. difficile toxin.
- Enhanced Toxigenic Culture: An established laboratory method for detecting toxigenic C. difficile.
- For discordant results, an "FDA-cleared molecular device" was used for reconciliation.
These are all forms of reference standard (laboratory-based) ground truth.
8. Sample Size for the Training Set
The document does not provide information on a training set sample size. The submission describes the performance validation of the instrument when used with a specific diagnostic assay, rather than the development and training of a machine learning algorithm. PCR instruments perform predefined biochemical reactions and detect fluorescence signals based on set parameters, they do not typically undergo "training" in the machine learning sense.
9. How the Ground Truth for the Training Set was Established
Since there is no mention of a training set for a machine learning algorithm, there is no information provided on how ground truth was established for a training set. The instrument's operation is based on established PCR principles and specified assay parameters.
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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.
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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:
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Predicates Comparison – Life Technologies QuantStudio™ Dx Real-Time PCR
Instrument vs. Abbott m2000™ System
| Item | Subject DeviceQuantStudio™ DxReal-Time PCRInstrument | Predicate DeviceAbbott m2000™ System | |
|---|---|---|---|
| Similarities | |||
| 510(k) | N/A | K092705 | |
| Regulation | 862.2570Instrumentation forclinical multiplex testsystems. | Same | |
| Product Code | OOI: Real-TimeNucleic AcidAmplification Systemfor Real TimeInstruments. | OOI: Real-Time NucleicAcid AmplificationSystem for Real TimeInstruments. | |
| Device Class | Class II | Same | |
| Intended Use | The QuantStudio™ Dx Real-Time PCRInstrument withQuantStudio™ DxSoftware is intended toperform fluorescence-based PCR to providedetection of FDAcleared and approvednucleic acid sequencesin human-derivedspecimens. TheQuantStudio™ DxReal-Time PCRInstrument withQuantStudio™ DxSoftware is intendedfor in vitro diagnosticuse by trainedlaboratorytechnologists incombination withnucleic acid reagentkits/tests manufacturedand labeled fordiagnostic purposes on | The Abbott m2000™System is intended for invitro diagnostic use inperforming FDA clearedand approved nucleic acidtesting in clinicallaboratories. It comprisesthe Abbott m2000sp andthe Abbott m2000rtinstruments. The Abbottm2000sp is an automatedsystem for performingsample preparation fornucleic acid testing. TheAbbott m2000rt is anautomated system forperforming fluorescence-based PCR to providequantitative and qualitativedetection of nucleic acidsequences. | |
| Item | Subject DeviceQuantStudio™ DxReal-Time PCRInstrument | Predicate DeviceAbbott m2000™ System | |
| Similarities | |||
| this instrument. | |||
| Technology/Detection | Real-Time PCR | Same | |
| Specimen Types | Nucleic acid | Same | |
| Assay Format | Homogeneous, closedtube PCR | Same | |
| Degree ofAutomation | Requires manualtransfer ofamplification mixturetoamplification/detectioninstrument.Automated control ofamplification,detection, and dataanalysis. | Same | |
| PrimaryOperationalAmplificationand DetectionComponents | Integrated thermalcycler andmicrovolumefluorimeter for walkaway PCRamplification anddetection | Same | |
| Heating Methodfor Amplification | Peltier device withsample block | Same | |
| DetectionProcedure | Optical detection ofstimulatedfluorescence | Same | |
| DetectionChemistries | Fluorescence labeledtarget-specific probes | Same | |
| Item | Subject DeviceQuantStudioTM Dx Real-Time PCR Instrument | Predicate DeviceAbbott 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. |
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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
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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.
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| Reproducibility Results – QuantStudio™ Dx Instrument | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| PanelMemberID | Site 1 | Site 2 | Site 3 | TotalResults | ||||||
| Results | AVECt | %CV | Results | AVECt | %CV | Results | AVECt | %CV | ||
| HighNegative0.3x LoD | 8/30 | 22.9 | 5.0 | 15/30 | 22.5 | 1.3 | 15/30 | 22.5 | 1.5 | 38/90 |
| LowPositive2x LoD | 30/30 | 20.4 | 5.9 | 30/30 | 19.0 | 5.1 | 30/30 | 19.2 | 0.8 | 90/90 |
| MedPositive5x LoD | 30/30 | 18.4 | 4.2 | 30/30 | 17.5 | 0.4 | 30/30 | 17.9 | 0.7 | 90/90 |
| NegativeSpecimen | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 |
| NegativeControl | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/30 | N/A | N/A | 0/90 |
| PositiveControl | 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.
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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 theQuidel MolecularDirect C. difficileAssay on theQuantStudioTM DxReal-Time PCRInstrument | ||
| Male | Female | Total | ||
| Unknown | 2 | 50% (1/2) | ||
| ≤ 2 years | 5 | 5 | 10 | 10% (1/10) |
| 2 to <12 years | 28 | 21 | 49 | 24% (12/49) |
| 12 to <18 years | 10 | 14 | 24 | 21% (5/24) |
| 18 to 21 years | 6 | 7 | 13 | 8% (1/13) |
| >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
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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 | |||||
| QuidelMolecularReal-TimePCRDirect C.difficileTox A/BAssay | 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.
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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% | ||
| QuidelMolecularDirect C.difficileAssay | 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
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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
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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_
§ 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.