(112 days)
The i-STAT Cardiac Markers Controls are an assayed liquid serum used to verify the integrity of newly received i-STAT cTnl cartridges.
The i-STAT Cardiac Markers Calibration Verification Controls are an assayed liquid serum used to verify the calibration of i-STAT cTnl cartridges throughout the reportable range.
The i-STAT Cardiac Markers Controls are supplied in three levels packaged as six vials of one level per box, with each vial containing 1 mL of control material. The three levels are each comprised of a different level of cardiac Troponin I, human creatinine kinase -- MB isoform CK-MB, and myoqlobin (all native forms) derived from human cardiac material, prepared in human serum, and preserved with sodium azide to inhibit microbial growth. The CK-MB and myoglobin are unassayed components in these materials. Only the cardiac troponin I (cTnl) values will be provided in the value assignment sheets for these products.
The Cardiac Markers Calibration Control Set is packaged as a tri-level set, comprised of two vials of each of three levels per box.
The acceptance criteria and study details for the i-STAT Cardiac Markers Control devices are described below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Within-level vial imprecision for all three levels of cardiac markers controls | Ranged from 1.9% to 5.7% |
| Stability after thawing (4 hours at 2 to 8°C) | All three levels meet the claim of 4 hours' stability |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document specifies "testing three lots of each control level" for the within-level vial imprecision study. The exact number of individual samples (vials) per lot is not provided.
- Data Provenance: Not explicitly stated, but given the context of a 510(k) submission, the data would typically be generated in-house by i-STAT Corporation (the manufacturer) in the United States, and would be prospective in nature, as it's a validation study for a new device.
3. Number of Experts and Qualifications
Not applicable. This device is a quality control material, not a diagnostic device requiring expert interpretation of images or patient data.
4. Adjudication Method
Not applicable for this type of device and study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a quality control material, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study was performed. The data presented ("within-level vial imprecision" and "stability after thawing") represents the intrinsic performance of the control material itself, without human interpretation in the workflow.
7. Type of Ground Truth Used
The ground truth for this device is based on the inherent biochemical properties of the control material (cardiac Troponin I, CK-MB, and myoglobin), prepared in human serum, and preserved. The "assayed" components (cTnI) would have their values established through validated reference methods.
8. Sample Size for the Training Set
Not applicable. This device is a quality control material, not an AI algorithm that requires a training set. The performance studies are validation studies for the control material itself.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device. The "ground truth" for the control material's values (specifically for the assayed cTnI) would be established through a rigorous value assignment protocol using reference methods and multiple measurements, typically by the manufacturer.
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OCT - 7 2003
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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: June 12, 2003
Submitted by:
i-STAT Corporation 104 Windsor Center Drive E. Windsor, NJ 08520 Phone: 609-443-9300 FAX: 609-443-9310
Contact:
Gregory W. Shipp, MD Vice-President, Medical Affairs i-STAT Corporation 104 Windsor Center Drive East Windsor, NJ 08520 Phone: 609-443-9300 Fax: 609-443-9310
Establishment Registration Number: 2245578
ldentification of Device:
Device Name: i-STAT Cardiac Markers Control Level 1 i-STAT Cardiac Markers Control Level 2 i-STAT Cardiac Markers Control Level 3 i-STAT Cardiac Markers Calibration Verification Control Set Proprietary/Trade Name: i-STAT Cardiac Markers Control Level 1 i-STAT Cardiac Markers Control Level 2 i-STAT Cardiac Markers Control Level 3 i-STAT Cardiac Markers Calibration Verification Control Set Common Name: cardiac marker controls, cardiac marker calibration verification set
Device Classification: I Requlation Number: 21 CFR§ 862.1660 Panel: Single (Specified) Analyte Controls (Assayed and Unassayed) Product Code: JJX
Identification of the Predicate Device: Device Name: More Diagnostics Cardiac Markers Control
Intended Use of the Devices:
Cardiac Markers Control (Level 1, Level 2, and Level 3)
The i-STAT Cardiac Markers Controls are an assayed liquid serum used to verify the integrity of newly received i-STAT cTnl cartridges.
Cardiac Markers Calibration Verification Control Set
The i-STAT Cardiac Markers Calibration Verification Controls are an assayed liquid serum used to verify the calibration of i-STAT cTnl cartridges throughout the reportable range.
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Ko31813
Description of the Device:
The i-STAT Cardiac Markers Controls are supplied in three levels packaged as six vials of one level per box, with each vial containing 1 mL of control material. The three levels are each comprised of a different level of cardiac Troponin I, human creatinine kinase -- MB isoform CK-MB, and myoqlobin (all native forms) derived from human cardiac material, prepared in human serum, and preserved with sodium azide to inhibit microbial growth. The CK-MB and myoglobin are unassayed components in these materials. Only the cardiac troponin I (cTnl) values will be provided in the value assignment sheets for these products.
The Cardiac Markers Calibration Control Set is packaged as a tri-level set, comprised of two vials of each of three levels per box.
Comparison to Technological Features of the Predicate Device:
The similarities and differences between the i-STAT controls products and the More Diagnostics control products can be seen in the table below.
| Characteristics | i-STAT Cardiac Markers ControlLevel 1, 2, & 3andi-STAT Cardiac MarkersCalibration Verification ControlSet(new device) | More Diagnostics CardiacMarkers Control(predicate device) |
|---|---|---|
| Similarities | ||
| Matrix | Human Serum | Human Serum |
| Preservative | Sodium Azide | Sodium Azide |
| Form | Frozen liquid | Frozen liquid |
| Opened Vial Claim | 4 hours when stored at 2 to 8°C | 4 hours when stored at 2 to 8°C |
| Differences | ||
| Analytes | CKMB (unassayed) | CKMB (assayed) |
| Myoglobin (unassayed) | Myoglobin (assayed) | |
| cTroponin I (assayed) | cTroponin I (assayed) | |
| Vial | 10 mL plastic vial with dropper-top | Plastic bulb |
| Fill volume | 1 mL | 300 μL |
| Storage (unopened) | ≤ -18°C | -14°C to -22 °C |
| until expiration date | until expiration date |
List of similarities and differences between the i-STAT and predicate device
Summary of Performance in Support of Substantial Equivalence:
- The within-level vial imprecision for all three levels of the i-STAT cardiac markers . controls was found to range from 1.9% to 5.7% testing three lots of each control level.
- Studies demonstrated that all three levels meet the claim of 4 hours' stability after the product . has been thawed.
Conclusions:
The i-STAT Cardiac Markers Control Level 1. Level 3. and the i-STAT Cardiac Markers Calibration Verification Control Set are substantially equivalent to the previously cleared More Diagnostics Cardiac Markers Control as indicated by the data.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT - 7 2003
Ms. Sue Kent Manager, Clinical Affairs i-STAT Corporation 104 Windsor Center Drive East Windsor, NJ 08520
K031873 Re:
Trade/Device Name: i-STAT Cardiac Markers Control Level 1 i-STAT Cardiac Markers Control Level 2 i-STAT Cardiac Markers Control Level 3 i-STAT Cardiac Markers Calibration Verification Control Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: September 2, 2003 Received: September 3, 2003
Dear Ms. Kent:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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a. Indications for use 3
510(k) Number (if known): __
Device Names: i-STAT Cardiac Markers Control Level 1 i-STAT Cardiac Markers Control Level 2 i-STAT Cardiac Markers Control Level 3
The i-STAT Cardiac Markers Controls are used to verify the integrity of newly received i-STAT cTnl cartridges.
KO31873
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)
Carl C Benson for Den Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K031873
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b. Indications for use 3 KO31873
510(k) Number (if known):
Device Name: i-STAT Cardiac Markers Calibration Verification Control Set
The i-STAT Cardiac Markers Calibration Verification Control Set is used to verify the accuracy of results over the measurement range of the i-STAT cTnl test.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)
Caurfc. Benam f. Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K031873
Page 1 of 1
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.