Who can help prepare an FDA 510(k) submission like AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE

Q: Who is the manufacturer of AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE?

Radiometer Medical Aps filed the 510(k) submission for AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE (K120326).

Q: What is the FDA product code for AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE?

JHX. It is classified under 21 CFR 862.1215 as a Class 2 device in the Clinical Chemistry panel.

Q: What is the regulatory pathway for AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE?

VIDAS Creatine Kinase MB (CKMB) Assay (K962549); VIDAS Creatine Kinase MB (CKMB) Calibrators (K962549); Liquicheck Cardiac Markers Plus Control LT (K050537).

K120326 · Radiometer Medical Aps · JHX · Nov 21, 2012 · Clinical Chemistry

Device Facts

Record ID	K120326
Device Name	AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE
Applicant	Radiometer Medical Aps
Product Code	JHX · Clinical Chemistry
Decision Date	Nov 21, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1215
Device Class	Class 2

Intended 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.

Device Story

Cartridge-based immunoassay; uses time-resolved fluorescence with europium (Eu) chelate label. Input: EDTA or lithium-heparin whole blood or plasma. Process: sample and assay buffer dispensed into test cup; incubation (7-15 min at 37°C) allows immuno-complex formation; wash step removes unbound material; cup dried; excitation light applied; emitted light measured via single photon counting. Output: quantitative CKMB concentration compared to calibration curve. Used in point-of-care and laboratory settings; operated by healthcare professionals. Results aid clinicians in diagnosing myocardial infarction, enabling rapid cardiac assessment.

Clinical Evidence

Bench testing only. Comparison study of AQT90 FLEX CKMB vs. VIDAS CKMB predicate using lithium-heparin plasma and whole blood. Sample ranges: 2.1-217 ng/mL (plasma) and 1.5-277 ng/mL (whole blood). Passing-Bablok regression showed high correlation (r² 0.95-0.99) across three POC sites. Imprecision: CV% total ≤ 8.2% (plasma) and ≤ 6.0% (whole blood). No interference from common blood components or 52 tested drugs.

Technological Characteristics

Cartridge-based immunoassay; time-resolved fluorescence; europium (Eu) chelate label. Sensing: single photon counting. Materials: test cups with dried reagents, anti-CKMB capture/tracer antibodies. Dimensions: 300 µL test cups. Connectivity: AQT90 FLEX analyzer. Calibration: lot-specific cartridge. Storage: 2-8°C.

Indications for Use

Indicated for quantitative determination of creatine kinase isoform MB in EDTA or lithium-heparin whole blood or plasma specimens to aid in the diagnosis of myocardial infarction in point of care and laboratory settings.

Regulatory Classification

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.

Predicate Devices

VIDAS Creatine Kinase MB (CKMB) Assay (K962549)
VIDAS Creatine Kinase MB (CKMB) Calibrators (K962549)
Liquicheck Cardiac Markers Plus Control LT (K050537)

Reference Devices

Ciba-Corning Magic Lite CK-MB assay

Related Devices

K984067 — STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK · Dade Behring, Inc. · Jan 13, 1999
K970343 — MMB METHOD · Dade Chemistry Systems, Inc. · Feb 14, 1997
K163462 — AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX · Radiometer Medical Aps · Sep 21, 2017
K033747 — RAMP CK-MB ASSAY · Response Biomedical Corp. · May 17, 2004
K051433 — I-STAT CREATINE KINASE MB (CK-MB) · I-Stat Corporation · Dec 15, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ K120326 ### 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: - 1. Metering of an exact amount of sample and assay buffer and dispensing into a test cup - 2. Incubating for 7-15 minutes at 37 °C - 3. Washing of the test cup to remove unbound tracer antibodies and sample material - 4. Drying the test cup - 5. 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}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the word "RADIOMETER" in bold, sans-serif font. To the right of the word is a registered trademark symbol. The symbol is a capital R inside of a circle. 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