Who is the manufacturer of I-STAT CREATINE KINASE MB (CK-MB)?

I-Stat Corporation filed the 510(k) submission for I-STAT CREATINE KINASE MB (CK-MB) (K051433).

What is the FDA product code for I-STAT CREATINE KINASE MB (CK-MB)?

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

What is the regulatory pathway for I-STAT CREATINE KINASE MB (CK-MB)?

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

What are the predicate devices for I-STAT CREATINE KINASE MB (CK-MB)?

Triage Cardiac Panel (CK-MB test).

Who can help prepare an FDA 510(k) submission like I-STAT CREATINE KINASE MB (CK-MB)?

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.

I-STAT CREATINE KINASE MB (CK-MB)

K051433 · I-Stat Corporation · MYT · Dec 15, 2005 · Clinical Chemistry

Device Facts

Record ID	K051433
Device Name	I-STAT CREATINE KINASE MB (CK-MB)
Applicant	I-Stat Corporation
Product Code	MYT · Clinical Chemistry
Decision Date	Dec 15, 2005
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1215
Device Class	Class 2

Intended Use

The i-STAT CK-MB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI).

Device Story

i-STAT CK-MB and cTnI tests are single-use cartridges for point-of-care use. User scans barcode; applies ~16 microliters of fresh whole blood to cartridge; inserts into i-STAT 1 Analyzer. Analyzer performs automated analysis: sample incubation with enzyme-linked antibody conjugate; sample discard; substrate/wash solution application; amperometric signal measurement via alkaline phosphatase cleavage. Results displayed on analyzer; stored for transfer. System provides rapid quantitative measurement of cardiac markers to assist clinicians in diagnosing myocardial infarction and monitoring cardiac status. Benefits include rapid turnaround time compared to central lab testing, facilitating timely clinical decision-making in emergency departments, ICUs, and CCUs.

Clinical Evidence

Clinical study compared i-STAT CK-MB to Abbott AxSYM plasma results in 263 patients presenting with chest pain. Deming regression analysis showed a slope of 1.01, intercept of -0.19, and correlation coefficient of 0.994 for all samples. For samples <20.0 ng/mL (n=234), slope was 0.993, intercept -0.05, and correlation 0.960. Non-clinical data established LLD of 0.6 ng/mL, insensitivity to hematocrit (0-70% PCV), and lack of significant interference from CK-BB or CK-MM isoforms.

Technological Characteristics

Single-use test cartridge; two-site ELISA; electrochemical sensing principle using alkaline phosphatase enzyme label; resistive heating for temperature control; automated fluidics; quantitative measurement; compatible with i-STAT 1 Analyzer.

Indications for Use

Indicated for the quantitative measurement of CK-MB mass in whole blood or plasma samples to aid in the diagnosis and treatment of myocardial infarction (MI) in patients presenting with symptoms of cardiac distress.

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

Triage Cardiac Panel (CK-MB test)

Reference Devices

i-STAT 1 Analyzer (K001387)

Related Devices

K031739 — I-STAT CARDIAC TROPONIN (CTNI) TEST · I-Stat Corporation · Sep 2, 2003
K990434 — CARESIDE CKMB · Careside, Inc. · Apr 19, 1999
K990439 — CARESIDE CK · Careside, Inc. · Apr 19, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ ## DEC 15 2005 K 051433 ### 510(k) Summary This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1900 and CFR 807.92. The assigned 510(k) number is: Summary prepared on: Sep 10, 2005 #### Submitted by: i-STAT Corporation 104 Windsor Center Drive E. Windsor, NJ 08520 FAX: 609-443-9310 Phone: 609-443-9300 #### Contact: Mike Zelin Vice-President, R&D i-STAT Corporation 104 Windsor Center Drive East Windsor, NJ 08520 Fax: 609-443-9310 Phone: 609-443-9300 #### Establishment Registration Number: 2245578 #### ldentification of Device: . Device Name: CK-MB Test Proprietary/Trade Name: i-STAT® CK-MB Test Common Name: CK-MB, Creatine Kinase MB Isoenzymes Device Classification: II Requlation Number: 21 CFR§ 862.1215 Panel: Biosensor, Immunoassay, Cpk Or Isoenzymes Product Code: MYT #### Identification of the Predicate Device: Device Name: CK-MB test, Triage Cardiac Panel for use on the Triage Meter. #### Intended Use of the Device: The i-STAT CK-MB test is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis of myocardial infarction (MI). The cartridge is to be used with the i-STAT 1 Analyzer bearing the (Immuno) symbol, but not with the i-STAT Portable Clinical Analyzer or the Philips Medical Systems (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-STAT System, the CK-MB test is to be used by trained health care professionals in accordance with a facility's policies and procedures. #### Description of the Device: The i-STAT CK-MB test is contained in a single-use test cartridge. In use, the user scans a bar code and then places approximately 16 uL of whole blood or plasma in the cartridge. After the cartridge is closed, it is inserted into the thermally controlled i-STAT 1 Analyzer, and all analytical steps are performed automatically. Patient and use information may be entered into the analyzer via a keypad during the automated analysis cycle. {1}------------------------------------------------ As the analyzer performs several quality checks and controls the temperature of the sensors via resistive heating to the underside of the sensor chips, the substratelwash fluid is released into a conduit within the cartridge and a metered volume of the sample over the sensor chips. The enzyme-linked antibody conjugate dissolves into the sample and the sample incubates for a controlled time. The sample is then pushed into a waste chamber and the substrate/wash solution is brought over the sensors. The alkaline phosphatase captured on the CK-MB sensor cleaves the substrate present in the substrate/wash fluid, giving rise to an amperometric signal which is measured. ### Comparison to Technological Features of the Predicate Device: The followig is a comparison of technological features of the i-STAT and Triage Cardiac Panel CK-MB methods: | Characteristic | Triage CK-MB | i-STAT CK-MB | |-----------------------|----------------------------|----------------------------| | Assay methodology | Two-site ELISA | Two-site ELISA | | Capture site | Heterogeneous | Heterogeneous | | Capture antibodies | Monoclonal | Monoclonal | | Enzyme label antibody | Polyclonal | Monoclonal | | Enzyme label | Fluorescent dye | Alkaline phosphatase | | Analysis sequence | Simultaneous capture/label | Simultaneous capture/label | | Analysis time | 16 minutes | 5 minutes | | Sample type | Whole blood or plasma | Whole blood or plasma | | Enzyme detection | Fluorescent | Electrochemical | ### Summary of Non-Clinical Performance in Support of Substantial Equivalence: - Studies established that the i-STAT CK-MB test is insensitive to hematocrit levels from 0 to . 70 %PCV. - . The CK-MB assay is not significantly influenced by the presence of CK-BB at 100 ng/mL or CK-MM at 10,000 ng/mL. - Studies established that the interference effects from common medications, particularly those . commonly prescribed to patients with cardiovascular conditions, were similar to the effects for those drugs on CK-MB of the Triage Cardiac Panel. - . Studies established that the lower limit of detection (LLD) for the i-STAT method is a comparable 0.6 ng/mL versus 1.0 ng/mL for the CK-MB of the Triage Cardiac Panel. - . The imprecision of the i-STAT CK-MB test using plasma controls was established using inhouse and user studies. The Level 1 control %CV was 11.9% at 5.9 ng/mL, the Level 2 control %CV was 10.4% at 25.8 ng/mL and the Level 3 control %CV was 10.0% at 90.1 ng/mL. This includes within-lot, lot-to-lot, vial-to-vial, analyzer-to-analyzer and operator-tooperator components of the imprecision. {2}------------------------------------------------ Summary of Clinical Test Performance is Support of Substantial Equivalence Claims: Studies conducted at clinical sites compared the results of the i-STAT CK-MB test to those of the CK-MB test on the Triage Cardiac Panel for samples from patients who presented to the hospital with chest pain. Heparinized whole blood and plasma samples were analyzed on the i-STAT System while plasma samples were analyzed on the Abbott AxSYM. The methods were compared using Deming regression analysis. The results are summarized in the table below: and the first the became of the comment of the status ் பட்டி மாவட்டத்தில் அமைந்து வருகிறது துடுப்பது திருவுகள் பல்கலை மாவட்டத்தில் ப | | Definition | i-STAT whole blood and plasma vs Abbott AxSYM plasma | | |-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|---------------------------------------------| | Statistic | | all samples | samples where [CK- MB] <20.0 ng/mL | | N | The number of patient samples included in the data set | 263 | 234 | | Mean | The average of the comparative method result over the sample population | 10.82 | 3.58 | | Range | The range of comparative method results obtained over the sample population | 0.04 - 224 | 0.04-15.05 | | Sxx | The pooled estimate of the within-sample standard deviation of the comparative method over the sample population | 1.84 | 0.34 | | Syy | The pooled estimate of the within-sample standard deviation of the test method over the sample population | 2.66 | 0.38 | | Slope | The Deming slope of the correlation | 1.01 | 0.993 | | Intercept | The Deming intercept of the correlation | -0.19 | -0.05 | | Correlation | The correlation coefficient determined from regression | 0.994 | 0.960 | | Sy.x | The standard error of the estimate of the regression of the regression of y (test method) on x (comparative method) calculated using the regular regression slope | 3.98 | 0.94 | #### Conclusions: Based on clinical and non-clinical data the i-STAT CK-MB test is insensitive to hematocrit level from 0 - 70 %PCV, is not significantly influenced by the presence of other CK isoforms, shows similar interference effects to common drugs as the CK-MB test on the Triage Cardiac Panel, and has a lower limit of detection (LLD) of 0.6 ng/mL than the CK-MB test on the Triage Cardiac Panel. Studies using plasma controls indicate adequate imprecision for low, mid-range, and high results. Clinical data indicates acceptable correlation to the predicate device. {3}------------------------------------------------ #### ldentification of Device: Proprietary/Trade Name: i-STAT® cTnl Test Name: Immunoassay Method, Troponin Subunit Device Classification: II Regulation Number: 21 CFR§ 862.1215 Product Code: MMI and and the many of the seat of the seat of the section the section the section to the 1:00 pm 1 personal Supplie 1121 ... #### Conclusions: Based on comparative data the i-STAT Tn1 test can be run on both heparanized and nonheparanized whole blood samples as contrasted with the original restriction to heparanized whole blood samples (along with plasma samples) as per the current indications for use statement. {4}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the bird symbol. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 DEC 15 2005 Ms. Sue Kent Manager, Clinical Affairs i-STAT Corporation 104 Windsor Center Drive East Windsor, NJ 08520 Re: k051433 Trade/Device Name: i-STAT CK-MB test i-STAT Cardiac Troponin I test Regulation Number: 21 CFR 862.1215 Regulation Name: 21 OFF 00211241128211241111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111 Regulatory Class: Class II Product Code: MYT, MMI Dated: November 26, 2005 Received: November 29, 2005 Dear Mr. Zelin: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaren or (x) fee 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 conniered phorts to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). alle Costicule 700 (710) that to nov requent to the general controls provisions of the Act. The I ou may, merelory, mans of the Act include requirements for annual registration, listing of general controls provincity 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 it may be subject to sach dadnedial dema Regulations (CFR), Parts 800 to 895. In addition, FDA ean be found in Ther announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Teast of advised that I Dris issuance or our device complies with other requirements of the Act mall 1 DA has made a determinations administered by other Federal agencies. You must of any it cacal statutes and regaranents, including, but not limited to: registration and listing (21 comply with an the Prec 201 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {5}------------------------------------------------ Page 2 - This letter will allow you to begin marketing your device as described in your Section 510(k) I his icher witi anow you to ogin finding of substantial equivalence of your device to a legally premation notification - The stassification for your device and thus, permits your device to proceed to the market. If you desire specific information about the application of labeling requirements to your device, If you desire specific information advertising of your device, please contact the Office of In of questions on the promie Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation other general information on your responsibilities under the Act from the I ou inay other general mormansional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Alberto Guts Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use K051433 (previously K031739) 510(k) Number (if known): i-STAT Cardiac Troponin I test Device Name: Indications For Use: The i-STAT Cardiac Troponin I (cTnl) test is an in vitro diagnostic test for the The FSTAT Oardiae Troponin I in whole blood or plasma. quantitative measurement of cardiac troponin I in whole blood ond tractm quantitative measurement of ourchas in the diagnosis and treatment of Measurements on cardiac troponial Fare accums and as and as a catients with acute myocardial infaretion and as a see a their relative risk of mortality. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Jivision Sign-Off Livision Sign-Off Page 1 of ____________________________________________________________________________________________________________________________________________________________________ Office of In Vitro Diagnostic Device Evaluation and Safety 10(k)_ Ko 51433 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {7}------------------------------------------------ # Indications for Use 510(k) Number (if known): K051433 i-STAT CK-MB test Device Name: Indications For Use: The i-STAT CKMB test is an in vitro diagnostic test for the quantitative measurement of The F-STAT CKMB test is an in vitto diagnoons too. Ios. CK-MB measurements creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements creatinine Kiflase MD mass in whole blood or pracma out procardial infarction (MI). can be used as an aid in the diagnosis and treatment of myocardial infarction (MI). Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Page 1 of ____________________________________________________________________________________________________________________________________________________________________ 22 - Ision Sign-Off Office of In Vit-o Diagnostic Device Waluation and Safety Kas1433