AQT90 FLEX analyzer is for in vitro diagnostic use. The instrument is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point-of-care and laboratory settings.

AQT90 FLEX Myo Test is an in vitro diagnostic assay for the quantitative determination of myoglobin in EDTA or lithium-heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is indicated for use as an aid in the rapid diagnosis of heart disease, e.g. acute myocardial infarction.

AOT90 FLEX Myo CAL cartridge is for in vitro diagnostic use. For calibration adjustment of the Myo Test, as indicated on the cartridge, on the AQT90 FLEX analyzer.

AQT90 FLEX LQC Multi-CHECK, Levels 1-3, is for in vitro diagnostic use. For use with the AQT90 FLEX analyzer as a liquid quality control serum (LQC) to monitor the precision of laboratory testing procedures for the analytes listed on the specification insert.

Device Description

The AOT90 FLEX is a cartridge-based immunoassay, based on time-resolved fluorescence using a europium (Eu) chelate as the fluorescent label. The test receptacles for the assay are 300 µL test cups, which contain the antibodies used for capture of the analyte, and the Eu chelate labeled antibodies used to trace the captured analyte. The sample is added to the test cup together with assay buffer. The cup is then incubated to allow formation of the immuno-complex, and subsequently washed to remove unbound antibodies and sample material. Finally, the cup is exposed to excitation light, and after a delay the emitted light generated by the fluorescent label is measured by single photon counting; this measurement cycle is repeated up to 3,300 times. The total count is then compared to an assay calibration curve to obtain a quantitative measurement of the analyte's concentration in the sample.

This technology uses dried reagents deposited in the test cups and in the calibration adjustment cups - no liquids other than the sample itself together with the assay buffer are required. Total assay time is less than 20 minutes.

AI/ML Overview

Here's an analysis of the provided text regarding the AQT90 FLEX Myo Test, Myo CAL cartridge, and LQC Multi-CHECK, detailing the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The provided document describes the AQT90 FLEX Myo Test being compared to a predicate device, the ARCHITECT STAT Myoglobin. The acceptance criteria are implicitly based on demonstrating substantial equivalence to the predicate device, particularly in terms of analytical performance.

A key performance metric presented is the correlation between the new device and the predicate device for Myoglobin measurements.

Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (AQT90 FLEX Myo Test)
Correlation with Predicate Device (Myoglobin)	High correlation (e.g., r² approaching 1.0) with the ARCHITECT STAT Myoglobin assay.	Whole Blood: y = 1.07 x ARCHITECT + 15, r² = 0.99
		Plasma: y = 1.02 x ARCHITECT + 13, r² = 0.99
Reportable Range	Comparable to predicate device (ARCHITECT STAT Myoglobin: 0.0-1,200.0 ng/mL)	20-900 ng/mL (µg/L)
Analytical Sensitivity	Comparable to predicate device (ARCHITECT STAT Myoglobin: ≤ 1.0 ng/mL at 95% CI)	Limit of quantitation 1 ng/mL (µg/L)
Imprecision (CV%)	Comparable to predicate device (ARCHITECT STAT Myoglobin: ≤ 10% for concentrations ≥ 40 ng/mL, 3.2-5.4% for controls)	Plasma: Within-run CV ≤ 2.5%, Total CV ≤ 5.2%
		Whole Blood: Within-run CV ≤ 3.7%, Total CV ≤ 3.7%
Interference	No significant interferences (same as predicate)	No significant interferences

Study Details

Sample sizes used for the test set and the data provenance:
- Whole Blood Samples: 157 samples
- Plasma Samples: 165 samples
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective, using existing samples to compare performance against a predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This study is a comparative method study for an in vitro diagnostic device, comparing its quantitative measurements against a previously cleared predicate device. "Ground truth" in this context is the quantitative measurement provided by the predicate device, not expert interpretation of images or clinical outcomes.
Adjudication method for the test set:
- Not Applicable. As mentioned above, this is a quantitative comparison, not a study requiring adjudication of expert interpretations.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This document describes an in vitro diagnostic device for quantitative measurement of myoglobin, not an AI-assisted diagnostic imaging device that involves human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes. The study presents the performance of the AQT90 FLEX Myo assay (the algorithm/device only) in measuring myoglobin concentrations and comparing these measurements directly to those obtained from the predicate device. There is no human-in-the-loop component in the measurement process itself.
The type of ground truth used:
- The "ground truth" for comparison was the measurements obtained from the predicate device: ARCHITECT STAT Myoglobin assay. This is considered a "reference standard" or "comparator method" for demonstrating substantial equivalence.
The sample size for the training set:
- Not explicitly stated in the provided text. The document describes a "comparison" study. For quantitative IVD devices, a "training set" in the machine learning sense is not typically discussed in 510(k) summaries as the device calibration and analytical method development process usually involves proprietary internal development and validation, separate from the clinical performance comparison against a predicate.
How the ground truth for the training set was established:
- Not explicitly stated. As noted above, typical IVD development involves extensive analytical validation. The "ground truth" for establishing the device's accuracy and precision during its development (analogous to a training phase) would involve reference materials, spiked samples, and potentially calibrators whose concentrations are established using highly accurate reference methods or certified reference materials. The provided document focuses on the comparison to the predicate device for regulatory submission.

Summary

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JAN 2 0 2012

$\CH/2i6$

510(k) Premarket Notification Submission

RADIOMETER R

AQT90 FLEX, Reagent Pack, Myo Test Kit, Myo CAL Cartridge and LQC Multi-CHECK

510(k) Summary

AQT90 FLEX AQT90 FLEX Myoqlobin Test Kit AQT90 FLEX Myoglobin CAL Cartridge AQT90 FLEX LQC Multi-CHECK

Manufacturer

Radiometer Medical ApS Aakandevej 21, DK-2700 Bronshoj, Denmark

Contact information

Radiometer Medical ApS Aakandevej 21 DK-2700 Bronshoj Denmark Att. Ms Jana S. Hellmann Vice President Global RA/QA Phone +45 3827 3827 Fax: +45 3827 2727 E-mail: jana.hellmann@radiometer.dk

Signature

Tan J. Hine

Jaña S. Hellmann

Date of preparation

January 16, 2011

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Image /page/1/Picture/1 description: The image contains the word "RADIOMETER" in bold, block letters. To the right of the word is a circled letter R, which is a registered trademark symbol. The letters are all capitalized and evenly spaced.

AOT90 FLEX, Reagent Pack, Myo Test Kit, Myo CAL Cartridge and LQC Multi-CHECK

1.	Device names and classifications
2.	Predicate device
3.	Device description / test principle
4.	Device intended use
5.	Medical device to which substantial equivalence is claimed
6.	Technological characteristics in comparison to predicate device
7.	Conclusion

1. Device names and classifications

· Proprietary name: AQT90 FLEX Class I Classification name: fluorometer for clinical use (21 CFR 862.2560) Product code: KHO
. Proprietary name: AQT90 FLEX Myo Test Kit Class II Classification name: myoglobin, antiserum, control use (21 CFR. 866.5680) Product code: DDR
· Proprietary name: AQT90 FLEX Myo CAL Cartridge Class II Classification name: calibrator, secondary (21 CFR. 862.1150) Product code: JIT
· Proprietary name: AQT90 LQC FLEX Multi-CHECK, Levels 1, 2 and 3 Class I Classification name: quality control material (assayed and unassayed) (21 CFR 862.1660) Product code: JJY

2. Predicate device

· ARCHITECT STAT Myoglobin, 510(k) number K042924
. ARCHITECT STAT Myoglobin Calibrators, 510(k) number K042924
· Liquicheck Cardiac Markers Plus Control LT, 510(k) number K050537

3. Device description / test principle

Page 2 of 9

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AQT90 FLEX, Reagent Pack, Myo Test Kit, Myo CAL Cartridge and LQC Multi-CHECK

is measured by single photon counting; this measurement cycle is repeated up to 3,300 times. The total count is then compared to an assay calibration curve to obtain a quantitative measurement of the analyte's concentration in the sample.

This technology uses dried reagents deposited in the test cups and in the calibration adjustment cups - no liguids other than the sample itself together with the assay buffer are required. Total assay time is less than 20 minutes. In summary, the procedure is as follows:

1. Metering of an exact amount of sample and assay buffer and dispensing into a test cup
1. Incubating for 7-15 minutes at 37 °C
1. Washing of the test cup to remove unbound tracer antibodies and sample material
1. Drying the test cup
1. Measuring

4. Device intended use

AQT90 FLEX is for in vitro diagnostic use. The AQT90 FLEX analyzer is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoaqulant has been added. It is intended for use in point-of-care and laboratory settings.

AQT90 FLEX Myo Test Kit includes 10 AQT90 FLEX Myo Test cartridges and one AQT90 FLEX Myo CAL cartridge. AQT90 FLEX Myo Test is an in vitro diagnostic assay for the guantitative determination of myoqlobin in EDTA or lithium-heparin whole blood or plasma specimens on the AOT90 FLEX analyzer in point of care and laboratory settings. It is indicated for use as an aid in the rapid diagnosis of heart disease, e.g. acute myocardial infarction.

AQT90 FLEX Myo CAL cartridge is for in vitro diagnostic use. For calibration adjustment of the Myo Test, as indicated on the cartridge, on the AQT90 FLEX analyzer.

AQT90 FLEX LQC Multi-CHECK, Levels 1, 2 and 3, is for in vitro diagnostic use. For use with the AOT90 FLEX analyzer as a liquid quality control serum (LQC) to monitor the precision of laboratory testing procedures for the analytes listed on the specification insert.

5. Medical device to which substantial equivalence is claimed

The AOT90 FLEX Myo Test Kit and Myo CAL cartridges are substantially equivalent in features and characteristics to the ARCHITECT STAT Myoglobin test and ARCHITECT STAT Myoglobin Calibrators, 510(k) number K042924.

The AOT90 LQC FLEX Multi-CHECK, Levels 1, 2 and 3, is substantially equivalent in features and characteristics to the Liquicheck Cardiac Markers Plus Control LT, 510(k) number K050537.

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AQT90 FLEX, Reagent Pack, Myo Test Kit, Myo CAL Cartridge and LQC Multi-CHECK

6. Technological characteristics in comparison to predicate device

AQT90 FLEX analyzer ARCHITECT i System Item Intended use The AQT90 FLEX analyzer is The ARCHITECT i System is for for in vitro diagnostic use. It is in vitro diagnostic use. It is an an immunoassay instrument an immunoassay instrument based on the quantitative based on the quantitative determination of time-resolved determination of fluorescence to estimate chemiluminescense to concentrations of analytes in measure and quantify analyte whole-blood and plasma concentration in plasma and specimens. It is intended for serum. use in point-of-care and laboratory settings. Test format A completely closed, fully The ARCHITECT i System is an automated system, using open, fully-automated, cartridge-based immunoassay system allowing immunoassays in disposable random and continuous cups. Offers possibility of access, and priority running 15 different processing. parameters at a time and has a total capacity of 200 tests without replenishment. Specimen Samples are identified from Samples are identified from identification the barcode on blood the barcode on blood collection test tube. The code is read collection test tube. The code is read automatically by the automatically by the analyzer. analyzer. Specimen sampling Blood is drawn into normal Blood is drawn into normal and handling vacuum test. The blood vacuum test tubes, which are collection tube is placed centrifuged to obatin plasma. directly in the analyzer. A The blood collection tube is volume of sample is placed directly in the analyzer. automatically drawn from the A volume of sample is tube through its rubber seal. automatically drawn from the The still closed tube is tube through its rubber seal. discarded. The used The still closed tube is immunoassay cup is discarded discarded. into a closed waste bin in the

Comparison of features for AQT90 FLEX analyzer and predicate device

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Item	AQT90 FLEX analyzer	ARCHITECT i System
	analyzer.
Calibration	The analyzer can beautomatically calibrated bymeans of calibration cartridgesat the time of test cartridge lotchange.	Calibration must be carried outeach time a new reagent lotnumber is used. Calibration isrun automatically.
Quality control	AQT FLEX LQC Multi-CHECK,Levels 1, 2 and 3 is a liquidquality control. Its barcodeincludes upper and lower limitsfor the control range.	Architect STAT Controls,Levels 1, 2 and 3.

AQT90 FLEX, Reagent Pack, Myo Test Kit, Myo CAL Cartridge and LQC Multi-CHECK

Comparison of features for AQT90 FLEX Myo Test and predicate device

Item	AQT90 FLEX Myo Test	ARCHITECT STAT Myoglobin
Intended use	The AQT90 FLEX Myo Test isan in vitro diagnostic assay forthe quantitative determinationof myoglobin in EDTA orlithium-heparin whole blood orplasma specimens on theAQT90 FLEX analyzer in pointof care and laboratory settings.It is indicated for use as an aidin the rapid diagnosis of heartdisease, e.g. acute myocardialinfarction.	ARCHITECT STAT Myoglobin isa chemiluminescentmicroparticle immunoassay(CMIA) for the quantitativedetermination of myoglobin inhuman serum and plasma onthe ARCHITECT i System withSTAT protocol capability.Myoglobin values are used toassist in the diagnosis ofmyocardial infarction (MI).
Test format	Cartridge with 16 test cups,each coated with anti-myoglobin capture antibodyand containing a separatinglayer as well as Eu-chelateanti-myoglobin tracer. Sampleand assay buffer are added tothe cup. After an incubationperiod the cup is washed withassay buffer and dried. Whenexposed to an excitation lightthe bound europium emits afluorescence, which ismeasured in cycles of singlephoton counting. The total	In the 1st step, sample andanti-myoglobin coatedparamagnetic microparticlesare mixed and incubated.Myoglobin present in thesample binds to the anti-myoglobin coatedmicroparticles. After washing,anti-myoglobin acridinium-labeled conjugate is added inthe 2nd step. Following anotherincubation and wash, pre-trigger and trigger solutionsare added to the reactionmixture. The resulting
Item	AQT90 FLEX Myo Test	ARCHITECT STAT Myoglobin
	count is then compared to anassay calibration curve toobtain a quantitativemeasurement of the analyte'sconcentration in the sample.	chemiluminescent reaction,which is measured as relativelights units (RLUs). A directrelationship exists between theamount of myoglobin in thesample and the RLUs detected.
Traceability	Scripps M0725	N/A
Antibodies	Mouse monoclonals for captureand tracer antibody	Mouse monoclonals for captureand tracer antibody
Sample type	Human whole blood andplasma	Human serum and plasma
Anticoagulants	EDTA, Li-heparin	Li-heparin, Na-heparin, EDTA
Controls	Recommended	Recommended
In-use stability	16 days on-board	30 days on-board
Storage temperature	2-8 °C	2-8 °C
Reportable /calibration range	Reportable range 20-900 ng/mL (µg/L)	Calibration range 0.0-1,200.0 ng/mL
Analytical sensitivity	Limit of quantitation 1 ng/mL(µg/L)	≤ 1.0 ng/mL at the 95% levelof confidence
Reference range	97.5th percentile for females is75 ng/mL (µg/L), for males142 ng/mL (µg/L)	99th percentile for females is106.0 ng/mL, for males154.9 ng/mL, total140.1 ng/mL
Imprecision	Across the reportable range,CV(%)within-run is ≤ 2.5% forplasma and ≤ 3.7% for wholeblood;CV(%)total is ≤ 5.2% forplasma and ≤ 3.7% for wholeblood	≤ 10% for myoglobinconcentrations ≥ 40 ng/mL.CV(%)total for controls is3.5-4.6% at 56.7-62.3 ng/mL,3.4-4.6% at 324.9-354.9 ng/mL, and 3.2-5.4% at785.2-848.1 ng/mL
Interference	No significant interferences	No significant interferences
Comparison withpredicate	Comparison with AbbottARCHITECT STAT Myoglobinassay, with 157 whole bloodsamples in the range 24-856µg/L (ng/mL), and 165 plasmasamples in the range 22-882	Comparison with AbbottAxSYM myoglobin assay, 234samples in the range 7.6 -1,188.7 ng/mLy = 0.99 x AXSYM + 2.88, r =0.99
Item	AQT90 FLEX Myo Test	ARCHITECT STAT Myoglobin
	AQT90 FLEX Myo assay:$y = 1.07 x ARCHITECT + 15,$$r^2 = 0.99$ with whole blood; $y$$= 1.02 x ARCHITECT + 13, r^2$$= 0.99$ with plasma

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Image /page/5/Picture/0 description: The image shows the word "RADIOMETER" in all caps, with a registered trademark symbol to the right of it. The text is in a bold, sans-serif font. The registered trademark symbol is a capital R inside of a circle, which is inside of a square.

AQT90 FLEX, Reagent Pack, Myo Test Kit, Myo CAL Cartridge and LQC Multi-CHECK

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v - start - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

510(k) Premarket Notification Submission

AQT90 FLEX, Reagent Pack, Myo Test Kit, Myo CAL Cartridge and LQC Multi-CHECK

Comparison of features for AQT90 FLEX Myo CAL and predicate device

Item	AQT90 FLEX Myoglobin CAL	ARCHITECT STATMyoglobin Calibrators
Intended use	The AQT90 FLEX Myo CALCartridge is for in vitrodiagnostic use. For calibrationadjustment of the Myo Test,as indicated on the cartridge,on the AQT90 FLEX analyzer.	The ARCHITECT STATMyoglobin Calibrators are forcalibration of the ARCHITECT iSystem with STAT protocolcapability when used for thequantitative determination ofmyoqlobin in human serum orplasma.
Constituents	Each CAL Cartridge containseight analyte-specificbackground cups and eightcups with added antigen	Purified cardiac myoglobin inTris buffer with stabilizers
Calibration adjustmentinterval	Once per lot of AQT90 FLEXMyo Test cartridges and asoften as required by relevantregulations	Upon new assay reagent lotnumber
In-use stability	24 hours on-board	30 days at 2-8 °C
Storage temperature	2-8 °C	-10 °C

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AQT90 FLEX, Reagent Pack, Myo Test Kit, Myo CAL Cartridge and LQC Multi-CHECK

Comparison of features for AQT90 FLEX Multi-CHECK and predicate device, the Liquicheck Cardiac Markers Plus Control LT

Item	AQT90 LQC FLEX Multi-CHECK	Liquicheck Cardiac MarkersPlus Control LT
Intended use	The AQT90 FLEX LQC Multi-CHECK, Levels 1-3 is for in vitro diagnostic use. For usewith the AQT90 FLEX analyzeras a liquid quality control,serum (LQC) to monitor theprecision of laboratory testingprocedures for the analyteslisted on the specificationinsert.	Liquicheck Cardiac MarkersPlus Control LT is intended foruse as quality control serum tomonitor the precision oflaboratory testing procedureslisting in the package insert.
Analytes contained	Myoglobin	B-type Natriuretic Peptide(BNP), Creatine Kinase (Total),C-Reactive Protein (CRP),Homocysteine, Digitoxin, N-terminal pro-B-type NatriureticPeptide (NT-proBNP), CKMB,Myoglobin, Troponin I,Troponin T.
Matrix	Human serum	Human serum
Storage temperature	$ {\leq} $ -18 $ ^{\circ} $ C	-20 $ ^{\circ} $ C to -70 $ ^{\circ} $ C untilexpiration date
In-use stability	4 days if stored unused at2-8 $ ^{\circ} $ C; 2 hours if storedunused at room temperature	20 days at 2-8 $ ^{\circ} $ C

Summary of clinical performance data

The AQT90 FLEX Myo assay (y) was compared to the predicate device, the ARCHITECT STAT Myoglobin (x) using Li-heparin whole blood samples in the range 24-856 µg/L (ng/mL) and plasma samples in the range of 22-882 ng/mL (ug/L) with the AQT90 FLEX Myo assay. The relationship between the two methods was determined by Passing-Bablok regression. The regression lines and correlation coefficients were found to be y = 1.07 x ARCHITECT + 15, r2 = 0.99 with whole blood, and y = 1.02 x ARCHITECT + 13, r2 = 0.99 with plasma.

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AQT90 FLEX, Reagent Pack, Myo Test Kit, Myo CAL Cartridge and LQC Multi-CHECK

7. Conclusion

The products listed in the table are substantially equivalent based on their indications for use and performance characteristics.

New Device	Predicate Device
AQT90 FLEX Myo Test Kit. Class II.Classification name: myoglobin, antigen,antiserum, control use,(21 CFR. 866.5680), product code DDR	ARCHITECT STAT Myoglobin, 510(k) numberK042924
AQT90 FLEX Myo CAL Cartridge. Class II.Classification name: calibrator, secondary,(21 CFR. 862.1150), product code JIT	ARCHITECT STAT Myoglobin Calibrators, 510(k)number K042924
AQT90 FLEX LQC Multi-CHECK, Levels 1, 2and 3. Class I. Classification name: qualitycontrol material (assayed and unassayed)(21 CFR 862.1660), product code JJY	Liquicheck Cardiac Markers Plus Control LT, 510(k)number K050537

・

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Image /page/9/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a traditional symbol of medicine, with three intertwined snakes and a staff.

10903 New Hampshire Avenue Silver Spring, MD 20993

Radiometer Medical ApS c/o Jana Hellmann Vice President Global RA/QA Aakandevej 21 Bronshoj, Denmark DK-2700

JAN 2 0 2012

K112161 Re:

Trade Name: Radiometer Medical ApS AQT90 Flex Myo Test, AQT90 FLEX Myo CAL cartridge, AQT90 FLEX LQC Multi-CHECK, Levels 1-3 and AQT90 FLEX analyzer Regulation Number: 21 CFR §866.5680 Regulation Name: Myoglobin immunological test system. Regulatory Class: Class II Product Code: DDR, JIT, JJY, KHO Dated: January 16, 2012 Received: January 20, 2012

Dear Ms. Hellmann:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) number (if known): K112161

Device name:

AQT90 FLEX analyzer AQT90 FLEX Myo Test Kit AQT90 FLEX LQC Multi-CHECK, Levels 1-3 AQT90 FLEX Myo CAL Cartridge

Intended use:

AOT90 FLEX Myo CAL cartridge is for in vitro diagnostic use. For calibration adjustment of the Myo Test, as indicated on the cartridge, on the AQT90 FLEX analyzer.

Prescription Use × (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801

Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Russe Shear

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k):

Regulation Number and Section

§ 862.2560 Fluorometer for clinical use.

(a)
Identification. A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes. Fluorescence is the property of certain substances of radiating, when illuminated, a light of a different wavelength. This device is used in conjunction with certain materials to measure a variety of analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Acceptance Criteria and Device Performance

Study Details

RADIOMETER R

510(k) Summary

Table of contents

1. Device names and classifications

2. Predicate device

3. Device description / test principle

4. Device intended use

5. Medical device to which substantial equivalence is claimed

6. Technological characteristics in comparison to predicate device

510(k) Premarket Notification Submission

Comparison of features for AQT90 FLEX Myo CAL and predicate device

Summary of clinical performance data

7. Conclusion

Page 2

§ 862.2560 Fluorometer for clinical use.