(293 days)
Not Found
No
The device description details a standard immunoassay technology based on time-resolved fluorescence and comparison to a calibration curve, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is an in vitro diagnostic assay used to quantify creatine kinase isoform MB in blood or plasma specimens, aiding in the diagnosis of myocardial infarction. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic assay" and is "intended for use as an aid in the diagnosis of myocardial infarction."
No
The device description clearly outlines a hardware analyzer (AQT90 FLEX analyzer) that performs immunoassay testing using physical cartridges, test cups, and fluorescence measurement. While software is undoubtedly involved in controlling the analyzer and processing the data, the core of the device is a physical instrument and consumables, not software alone.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the AQT90 FLEX CKMB Test, AQT90 FLEX CKMB CAL cartridge, and AQT90 FLEX LQC Multi-CHECK are "in vitro diagnostic assays" or "for in vitro diagnostic use."
- Device Description: The description details a method for analyzing biological samples (whole blood or plasma) outside of the body ("in vitro") to measure a specific analyte (creatine kinase isoform MB).
- Function: The device is designed to provide quantitative measurements of a substance in a biological sample to aid in the diagnosis of a medical condition (myocardial infarction).
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AQT90 FLEX CKMB Test is an in vitro diagnostic assay for the quantitative determination of creatine kinase isoform MB in EDTA or lithium-heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the diagnosis of myocardial infarction.
AQT90 FLEX CKMB CAL cartridge is for in vitro diagnostic use for the calibration of the CKMB Test on the AQT90 FLEX analyzer by establishing points of reference to estimate CKMB values.
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
JHX, JIT, JJY
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. In summary, the procedure is as follows:
- Metering of an exact amount of sample and assay buffer and dispensing into a test cup
- Incubating for 7-15 minutes at 37 °C
- Washing of the test cup to remove unbound tracer antibodies and sample material
- Drying the test cup
- Measuring
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
The AQT90 FLEX CKMB assay (y) was compared to the predicate device, the VIDAS Creatine Kinase MB (CKMB) Assay (x) using lithium-heparin plasma and whole blood samples in the range of 2.1 - 217 ng/mL (µg/L) and 1.5 - 277 ng/mL (µg/L), respectively. The relationship between the two methods was determined by Passing-Bablok regression. The regression lines and correlation coefficients for whole blood samples were for POC Site 1 = 0.93x - 0.2; n = 43; r squared = 0.99, for POC Site 2 = 0.93x + 0.0; n = 46; r squared = 0.98 and for POC Site 3 = 0.96x - 0.5; n = 48; r squared = 0.95. For plasma samples the regressions lines and correlation coefficients were for POC Site 1 = 0.94x -0.3; n = 44; r squared = 0.99, for POC Site 2 = 0.96x + 0.0; n = 46; r squared = 0.99 and for POC Site 3 = 0.93x - 0.4; n = 48; r squared = 0.95.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.
0
RADIOMETER 16
510(k) Premarket Notification Submission AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge and LQC Multi-CHECK
510(k) Summary
AQT90 FLEX CKMB Test Kit AQT90 FLEX CKMB 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. Mrs Jana S. Hellmann Vice President, Global RA/QA Phone +45 3827 3827 Fax: +45 3827 2727 E-mail: jana.hellmann@radiometer.dk
Application correspondent
Radiometer Medical ApS Aakandevej 21 DK-2700 Bronshoj Denmark Att. Mrs Gitte Juel Frils Director, Regulatory Affairs · Phone +45 3827 3384 Fax: +45 3827 2727 E-mail: gitte.friis@radiometer.dk
Signature
Jau S. Her
Jana S. Hellmann 26 October, 2012
ﻳﺔ
Page 1 of 9
NOV 2 1 2012
1
Image /page/1/Picture/0 description: The image shows the word "RADIOMETER" in bold, sans-serif font. To the right of the word is a registered trademark symbol, which is a capital "R" inside of a circle. The text is black and the background is white. The image is a logo or brand name.
AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge and LQC Multi-CHECK
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 | |
| 7. | Conclusion |
1. Device names and classifications
- · Proprietary name: AQT90 FLEX CKMB Test Kit Class II Classification name: Creatine phosphokinase/creatine kinase or isoenzymes test system (21 CFR. 862.1215) Product code: JHX
- · Proprietary name: AQT90 FLEX CKMB 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
- · VIDAS Creatine Kinase MB (CKMB) Assay, 510(k) number K962549
- VIDAS Creatine Kinase MB (CKMB) Calibrators, 510(k) number K962549
- · 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 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.
Page 2 of 9
2
Image /page/2/Picture/1 description: The image shows the word "RADIOMETER" in bold, black, sans-serif font. To the right of the word is a registered trademark symbol, which is a capital "R" inside of a circle. The symbol is also in bold, black font. The background of the image is white.
AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge and LQC Multi-CHECK
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. In summary, the procedure is as follows:
-
- Metering of an exact amount of sample and assay buffer and dispensing into a test cup
-
- Incubating for 7-15 minutes at 37 °C
-
- Washing of the test cup to remove unbound tracer antibodies and sample material
-
- Drying the test cup
-
- Measuring
.
4. Device intended use
AQT90 FLEX CKMB Test Kit includes 10 AQT90 FLEX CKMB Test cartridges and one AQT90 FLEX CKMB CAL cartridge. AQT90 FLEX CKMB is an in vitro diagnostic assay for the quantitative determination of creatine kinase isoform MB in EDTA or lithium-heparin whole-blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the diagnosis of myocardial infarction.
AQT90 FLEX CKMB CAL cartridge is for in vitro diagnostic use intended for the calibration of the CKMB test on the AQT90 FLEX analyzer by establishing points of reference to estimate CKMB values.
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.
5. Medical device to which substantial equivalence is claimed
The AOT90 FLEX CKMB Test Kit and CKMB CAL cartridges are substantially equivalent in features and characteristics to the VIDAS Creatine Kinase MB (CKMB) Assay and the VIDAS Creatine Kinase MB (CKMB) Calibrator, 510(k) number K962549.
The AOT90 LOC 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
.
510(k) Premarket Notification Submission
. .
AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge and LQC Multi-CHECK
6. Technological characteristics in comparison to predicate device
Comparison of features for AQT90 FLEX CKMB Test and predicate device
| Item | AQT90 FLEX CKMB Test | VIDAS Creatine Kinase MB
(CKMB) Assay |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The AQT90 FLEX CKMB is an in
vitro diagnostic assay for the
quantitative determination of
creatine kinase isoform MB in
EDTA or lithium-heparin
whole-blood or plasma
specimens on the AQT90 FLEX
analyzer in point of care and
laboratory settings. It is
intended for use as an aid in
the diagnosis of myocardial
infarction. Current
international guidelines should
always be followed when
interpreting CKMB results. | The VIDAS Creatine Kinase MB
(CKMB) Assay is for in vitro
diagnosis and intended for use
on the instruments of the
VIDAS family (Vitek
ImmunoDiagnostic Assay
System) as an automated
enzyme-linked fluorescent
immunoassay (ELFA) for the
quantitative determination of
creatine kinase MB isoenzyme
concentration in human serum
or plasma (heparin or
EDTA). It is intended for use
as an aid in the diagnosis of
acute myocardial infarctions. |
| Test format | Cartridge with 16 test cups,
each coated with anti-CKMB
capture antibody and
containing a separating layer
as well as Eu-chelate anti-
CKMB tracer. Sample and
assay buffer are added to the
cup. Assay buffer is located in
the Reagent Pack. The pack
also receives the discarded
cups and liquid waste. After an
incubation period, a wash step
with assay buffer removes
unbound material from the
cup, which is subsequently
dried. When exposed to an
excitation light the bound
europium emits a fluorescence,
which is measured in cycles of
single photon counting. The
total count is then compared to
an assay calibration curve to
obtain a quantitative
measurement of the analyte's
concentration in the sample. | The VIDAS Creatine Kinase MB
(CKMB) assay is an enzyme-
linked fluorescent
immunoassay that is
performed in an automated
instrument. All assay steps and
assay temperature are
controlled by the instrument. A
pipette tip-like disposable
device, the Solid Phase
Receptacle (SPR), serves as a
solid phase for the assay as
well as a pipetting device. The
SPR is coated at the time of
manufacture with mouse
monoclonal anti-Creatine
Kinase MB antibodies. The
VIDAS Creatine Kinase MB
(CKMB) assay configuration
prevents nonspecific reactions
with the SPR. Reagents for the
assay are located in the sealed
Reagent Strips. A prewash
step prepares the SPR for the
reaction then the sample is
transferred into the well
containing the sample diluent.
Wash steps remove unbound |
| Item | AQT90 FLEX CKMB Test | VIDAS Creatine Kinase MB
(CKMB) Assay |
| | | material. The conjugate is then
cycled in and out of the SPR.
This step allows the conjugate
to attach to the CKMB already
fixed to the SPR: thus forming
a "sandwich". Wash steps
remove unbound conjugate. A
fluorescent substrate, 4-
methylumbelliferyl phosphate,
is cycled through the SPR.
Enzyme remaining on the SPR
wall will catalyze the
conversion of the substrate to
the fluorescent product 4-
methylumbelliferone. The
intensity of fluorescence is
measured by the optical
scanner in the instrument; it is
proportional to the Creatine
Kinase MB concentration
present in the sample. When
the VIDAS Creatine Kinase MB
(CKMB) Assay is completed,
the results are analyzed
automatically by the
instrument, and a report is
printed for each sample. |
| Traceability | ERM-AD455/IFCC | Not known |
| Antibodies | Mouse monoclonals for capture
and tracer antibody | Mouse monoclonal for capture
and goat polyclonal for tracer
antibody |
| Sample type | Human whole blood and
plasma | Human serum and plasma |
| Anticoagulants | EDTA, Li-heparin | EDTA, heparin |
| Controls | Recommended | Recommended |
| In-use stability | 23 days on-board up to 32 °C | Solid Phase Receptacle not to
be left outside 2-8 °C for
extended period of time. |
| Storage temperature | 2-8 °C | 2-8 °C |
| Reportable /
calibration range | Reportable range 1.5-
300 ng/mL (µg/L) | 0.8-300 ng/mL |
| Item | AQT90 FLEX CKMB Test | VIDAS Creatine Kinase MB (CKMB) Assay |
| Analytical sensitivity | Limit of Quantitation 1 ng/mL
(µg/L) | Limit of Detection is 0.8 ng/mL
at the 95% level of confidence |
| Reference range | 97.5th percentile for females is
6.9 ng/mL (µg/L), for males 11
ng/mL (µg/L). | 99th percentile is 6.8 ng/mL |
| Imprecision | Across the reportable range,
CV(%)within-run is ≤ 6.5% for
plasma and ≤ 6.0% for whole
blood;
CV(%)total is ≤ 8.2% for
plasma and ≤ 6.0% for whole
blood. | CV(%)intraassay range is ≤ 6.2%;
CV(%)interassay is ≤ 7.2%;
CV(%)total is ≤ 16.7% |
| Interference | No interference with CKBB,
CKMM, hemoglobin,
triglycerides, bilirubin and
other endogenous blood
components. No interference
with any of 52 drugs and
solvents tested. | No interference with CKBB and
CKMM; no interference with
hemoglobin, triglycerides and
bilirubin. |
| Comparison with
predicate | Comparison with VIDAS
Creatine Kinase MB (CKMB)
Assay.
Whole blood vs VIDAS:
POC Site 1 = 0.93x - 0.2; n =
43; r² = 0.99
POC Site 2 = 0.93x + 0.0; n =
46; r² = 0.98
POC Site 3 = 0.96x - 0.5; n =
48; r² = 0.95
Plasma vs VIDAS:
POC Site 1 = 0.94x - 0.3; n =
44; r² = 0.99
POC Site 2 = 0.96x + 0.0; n =
46; r² = 0.99
POC Site 3 = 0.93x - 0.4; n =
48; r² = 0.95 | Comparison with Ciba-Corning
Magic Lite CK-MB assay, 175
samples in the range 0.8 -300
ng/mL
y = 0.83x - 0.66, r = 0.97. |
Page 4 of 9
4
RADIOMETER B
510(k) Premarket Notification Submission
AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge and LQC Multi-CHECK
5
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AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge and LQC Multi-CHECK
6
Image /page/6/Picture/0 description: The image shows the word "RADIOMETER" in bold, black letters. To the right of the word is a circled R symbol. The font is sans-serif and the image is in black and white.
AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge and LQC Multi-CHECK
Comparison of features for AQT90 FLEX CKMB CAL and predicate device, the VIDAS Creatine Kinase MB (CKMB) Calibrators
| Item | AQT90 FLEX CKMB CAL | VIDAS Creatine Kinase MB
(CKMB) Calibrator |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The AQT90 FLEX CKMB CAL
Cartridge is for in vitro
diagnostic use and intended
for the calibration of the CKMB
test on the AQT90 FLEX
analyzer by establishing points
of reference to estimate
CKMB values. | The VIDAS Creatine Kinase MB
(CKMB) Calibrator is for in
vitro diagnostic use and
intended for calibration of the
VIDAS Creatine Kinase MB
(CKMB) assay by verification
of the master calibration
curve. |
| Constituents | Each CAL Cartridge contains
eight analyte-specific
background cups and eight
cups with added antigen. | 1 x 3 mL (lyophilized) |
| Calibration adjustment
interval | Once per lot of AQT90 FLEX
CKMB Test cartridges and as
often as required by relevant
regulations. | Upon receipt of new lot of
assay reagents and every 14
days thereafter. |
| In-use stability | 24 hours on-board up to 32 °C | 24 hours at 2-8 °C when
reconstituted;
until expiry date at 25±6 °C
when reconstituted |
| Storage temperature | 2-8 °C | 2-8 °C or -25±6 °C when
reconstituted |
7
Image /page/7/Picture/0 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 text is black and the background is white.
AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge and LQC Multi-CHECK
Comparison of features for AQT90 FLEX LQC 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 | CKMB, 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 | ≤ -18 ºC until expiration date;
shelf life claim is 12 months. | -20 °C to -70 °C until
expiration date. |
| In-use stability | 4 days if stored unused at
2-8 ºC; 2 hours if stored
unused at room temperature
15-32 °C. | 20 days at 2-8 °C |
Summary of clinical performance data
The AQT90 FLEX CKMB assay (y) was compared to the predicate device, the VIDAS Creatine Kinase MB (CKMB) Assay (x) using lithium-heparin plasma and whole blood samples in the range of 2.1 - 217 ng/mL (µg/L) and 1.5 - 277 ng/mL (µg/L), respectively. The relationship between the two methods was determined by Passing-Bablok regression. The regression lines and correlation coefficients for whole blood samples were for POC Site 1 = 0.93x - 0.2; n = 43; r2 = 0.99, for POC Site 2 = 0.93x + 0.0; n = 46; r² = 0.98 and for POC Site 3 = 0.96x - 0.5; n = 48; ~ = 0.95. For plasma samples the regressions lines and correlation coefficients were for POC Site 1 = 0.94x -0.3; n = 44; ~ = 0.99, for POC Site 2 = 0.96x + 0.0; n = 46; ~ = 0.99 and for POC Site 3 = 0.93x - 0.4; n = 48; r2 = 0.95.
8
RADIOMETER B
510(k) Premarket Notification Submission
AQT90 FLEX CKMB Test Kit, CKMB 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 CKMB Test Kit. Class II. | |
| Classification name: Creatine | |
| phosphokinase/creatine kinase or | |
| isoenzymes test system (21 CFR. | |
| 862.1215), product code JHX | VIDAS Creatine Kinase MB (CKMB) Assay, 510(k) |
| number K962549 | |
| AQT90 FLEX CKMB CAL Cartridge. Class II. | |
| Classification name: calibrator, secondary, | |
| (21 CFR. 862.1150), product code JIT | VIDAS Creatine Kinase MB (CKMB) 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/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 21, 2012
Radiometer Medical ApS c/o Gitte Friis Director, Regulatory Affairs Aakandejev 21 Bronshoj, Denmark DK 2700
K120326 Re:
Trade/Device Name: AQT90 FLEX CKMB Test Kit; AQT90 FLEX CKMB CAL Cartridge; AQT90 FLEX LQC Multi-CHECK, Levels 1-3 Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHX, JIT, JIT, JJY Dated: October 26, 2012 Received: October 31, 2012
Dear Gitte Friis:
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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) segulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
10
Page 2 - Gitte Friis
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
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/cdrh/industry/support/index.html.
Sincerely yours,
Carol C? Benson
for
Courtney H. Lias, Ph.D.
Director
Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
11
Indications for Use
510(k) Number (if known): K120326
AQT90 FLEX CKMB Test Kit Device Name: AQT90 FLEX CKMB CAL Cartridge AQT90 FLEX LQC Multi-CHECK, Levels 1-3
Indications for Use:
AOT90 FLEX CKMB Test is an in vitro diagnostic assay for the quantitative determination of creatine kinase isoform MB in EDTA or lithium-heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the diagnosis of myocardial infarction.
AQT90 FLEX CKMB CAL cartridge is for in vitro diagnostic use for the calibration of the CKMB Test on the AQT90 FLEX analyzer by establishing points of reference to estimate CKMB values.
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 X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Page 1 of
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Rutos Chube
Division Sian-Off Office of In Vitro Diagnostics and Radiological Health (OIR)
510(k) K120326