Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard immunoassay technology based on time-resolved fluorescence and calibration curves, with no mention of AI or ML.

Therapeutic

No
The device is an in vitro diagnostic immunoassay instrument used for measuring biomarkers to aid in diagnosis, not to treat a condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "AQT90 FLEX analyzer is for in vitro diagnostic use." and "AQT90 FLEX Myo Test is an in vitro diagnostic assay". It also mentions its use "as an aid in the rapid diagnosis of heart disease". These phrases clearly indicate its diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a hardware-based immunoassay instrument that uses physical components like test cups, reagents, and a fluorescence measurement system. It is not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "AQT90 FLEX analyzer is for in vitro diagnostic use." and "AQT90 FLEX Myo Test is an in vitro diagnostic assay..." and "AOT90 FLEX Myo CAL cartridge is for in vitro diagnostic use." and "AQT90 FLEX LQC Multi-CHECK, Levels 1-3, is for in vitro diagnostic use."
Purpose: The device is designed to analyze biological specimens (whole blood and plasma) in vitro (outside of the body) to determine the concentration of clinically relevant markers (myoglobin).
Clinical Relevance: The results are intended to be used as an aid in the rapid diagnosis of heart disease, which is a clinical application.
Components: The description includes components typically associated with IVD systems, such as an analyzer, test cartridges, calibration cartridges, and quality control materials, all intended for in vitro use.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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 1-3, 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.

Product codes (comma separated list FDA assigned to the subject device)

KHO, DDR, JIT, JJY

Device Description

The AQT90 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Heart

Indicated Patient Age Range

Not Found

Intended User / Care Setting

point-of-care and laboratory settings

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K042924, K050537

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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

1

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

· 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

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

Page 2 of 9

2

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.

3

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

4

Item	AQT90 FLEX analyzer	ARCHITECT i System
	analyzer.
Calibration	The analyzer can be
automatically calibrated by
means of calibration cartridges
at the time of test cartridge lot
change.	Calibration must be carried out
each time a new reagent lot
number is used. Calibration is
run automatically.
Quality control	AQT FLEX LQC Multi-CHECK,
Levels 1, 2 and 3 is a liquid
quality control. Its barcode
includes upper and lower limits
for 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 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.	ARCHITECT STAT Myoglobin is
a chemiluminescent
microparticle immunoassay
(CMIA) for the quantitative
determination of myoglobin in
human serum and plasma on
the ARCHITECT i System with
STAT protocol capability.
Myoglobin values are used to
assist in the diagnosis of
myocardial infarction (MI).
Test format	Cartridge with 16 test cups,
each coated with anti-
myoglobin capture antibody
and containing a separating
layer as well as Eu-chelate
anti-myoglobin tracer. Sample
and assay buffer are added to
the cup. After an incubation
period the cup is washed with
assay buffer and dried. When
exposed to an excitation light
the bound europium emits a
fluorescence, which is
measured in cycles of single
photon counting. The total	In the 1st step, sample and
anti-myoglobin coated
paramagnetic microparticles
are mixed and incubated.
Myoglobin present in the
sample binds to the anti-
myoglobin coated
microparticles. After washing,
anti-myoglobin acridinium-
labeled conjugate is added in
the 2nd step. Following another
incubation and wash, pre-
trigger and trigger solutions
are added to the reaction
mixture. The resulting
Item	AQT90 FLEX Myo Test	ARCHITECT STAT Myoglobin
	count is then compared to an
assay calibration curve to
obtain a quantitative
measurement of the analyte's
concentration in the sample.	chemiluminescent reaction,
which is measured as relative
lights units (RLUs). A direct
relationship exists between the
amount of myoglobin in the
sample and the RLUs detected.
Traceability	Scripps M0725	N/A
Antibodies	Mouse monoclonals for capture
and tracer antibody	Mouse monoclonals for capture
and tracer antibody
Sample type	Human whole blood and
plasma	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% level
of confidence
Reference range	97.5th percentile for females is
75 ng/mL (µg/L), for males
142 ng/mL (µg/L)	99th percentile for females is
106.0 ng/mL, for males
154.9 ng/mL, total
140.1 ng/mL
Imprecision	Across the reportable range,
CV(%)within-run is ≤ 2.5% for
plasma and ≤ 3.7% for whole
blood;
CV(%)total is ≤ 5.2% for
plasma and ≤ 3.7% for whole
blood	≤ 10% for myoglobin
concentrations ≥ 40 ng/mL.
CV(%)total for controls is
3.5-4.6% at 56.7-62.3 ng/mL,
3.4-4.6% at 324.9-
354.9 ng/mL, and 3.2-5.4% at
785.2-848.1 ng/mL
Interference	No significant interferences	No significant interferences
Comparison with
predicate	Comparison with Abbott
ARCHITECT STAT Myoglobin
assay, with 157 whole blood
samples in the range 24-856
µg/L (ng/mL), and 165 plasma
samples in the range 22-882	Comparison with Abbott
AxSYM myoglobin assay, 234
samples in the range 7.6 -
1,188.7 ng/mL
y = 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

6

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 STAT
Myoglobin Calibrators |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The 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. | The ARCHITECT STAT
Myoglobin Calibrators are for
calibration of the ARCHITECT i
System with STAT protocol
capability when used for the
quantitative determination of
myoqlobin in human serum or
plasma. |
| Constituents | Each CAL Cartridge contains
eight analyte-specific
background cups and eight
cups with added antigen | Purified cardiac myoglobin in
Tris buffer with stabilizers |
| Calibration adjustment
interval | Once per lot of AQT90 FLEX
Myo Test cartridges and as
often as required by relevant
regulations | Upon new assay reagent lot
number |
| In-use stability | 24 hours on-board | 30 days at 2-8 °C |
| Storage temperature | 2-8 °C | -10 °C |

7

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 Markers
Plus Control LT |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The 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. | Liquicheck Cardiac Markers
Plus Control LT is intended for
use as quality control serum to
monitor the precision of
laboratory testing procedures
listing 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 Natriuretic
Peptide (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 until
expiration date |
| In-use stability | 4 days if stored unused at
2-8 $ ^{\circ} $ C; 2 hours if stored
unused 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.

8

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) number
K042924
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, 2
and 3. Class I. Classification name: quality
control material (assayed and unassayed)
(21 CFR 862.1660), product code JJY	Liquicheck Cardiac Markers Plus Control LT, 510(k)
number K050537

·

・

9

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

10

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

11

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:

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.

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):

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

§ 862.2560 Fluorometer for clinical use.

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