(55 days)
465908, 465909, 465910
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No
The document describes calibrators for a laboratory analyzer and does not mention any AI or ML components.
No
The device is a calibrator used to establish points of reference for the quantitative determination of substances in patient specimens; it is not used to treat diseases or conditions.
No.
This device is a calibrator, used to establish points of reference for the measurement of substances, not to directly diagnose a condition or disease.
No
The device is described as "Calibrators," which are physical substances used to calibrate laboratory instruments. The description of performance studies also refers to "reagents and wash solutions," further indicating a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the calibrators are used for the "quantitative determination of sodium, potassium, chloride, urea, glucose, creatinine, calcium and total CO2" in specimens using specific laboratory systems. This is a classic definition of an in vitro diagnostic product.
- Function: The calibrators "establish points of reference that are used in the determination of values in the measurement of substances in specimens." This is the core function of a calibrator in an in vitro diagnostic test.
- Care Setting: It is indicated for "professional use only," which is typical for IVD products used in clinical laboratories.
The information provided strongly indicates that these calibrators are used in a laboratory setting to perform diagnostic tests on biological specimens, which falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HiChem® Calibrators 1, 2 and 3 are intended to calibrate the Beckman® SYNCHRON CX® DELTA and CX® CE® Systems for the quantitative determination of sodium, potassium, chloride, urea, giucose, creatinine, calcium and total CO2.
HiChem® Calibrators 1, 2 and 3 for the SYNCHRON CX® DELTA and CX® CE® Systems are intended to establish points of reference that are used in the determination of values in the measurement of substances in specimens.
Product codes
JIX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
professional use only.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Method Comparison: Serum, plasma, urine and CSF were collected from adult patients and assayed using HiChem® and Beckman® calibrators, reagents and wash solutions on a SYNCHRON CX® DELTA System. Results were compared by least squares linear regression. Sample sizes include:
Calcium: Serum/Plasma (160), Urine (74)
Chloride: Serum/Plasma (160), Urine (78), CSF (44)
Potassium: Serum/Plasma (160), Urine (80)
Sodium: Serum/Plasma (160), Urine (78)
Total CO2: Serum/Plasma (160)
BUN: Serum/Plasma (160), Urine (79)
Glucose: Serum/Plasma (159), Urine (81), CSF (45)
Creatinine: Serum/Plasma (160), Urine (79)
Key results are provided in a table with regression statistics (n, a, b, r) and summary statistics (range, mean X, mean Y) for each analyte and specimen type.
Key Metrics
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Predicate Device(s)
SYNCHRON® CX® Calibrators 1, 2 & 3, product nos. 465908, 465909 and 465910
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
K99 28415
élan diagnostics
Image /page/0/Picture/2 description: The image is a black and white logo for "élan". The logo features a stylized letter "e" formed by multiple parallel lines that curve around to create the shape. To the left of the "e", there are several short, horizontal lines that resemble a stylized wing or speed lines. Below the graphic element, the word "élan" is written in a bold, sans-serif font, with an acute accent over the "e".
Summary of 510(k) Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
HiChem® Calibrators 1, 2 and 3 are intended to calibrate the Beckman® SYNCHRON CX® DELTA and CX® CE® Systems for the quantitative determination of sodium, chloride, urea, glucose, creatinine, calcium and total CO2. The HiChem® Calibrator 1 Kit, Calibrator 2 Kit and Calibrator 3 Kit are substantially equivalent to the SYNCHRON® CX® Calibrators 1, 2 & 3, product nos. 465908, 465909 and 465910, manufactured by Beckman Coulter, Inc.
The effectiveness of the HiChem® Calibrators 1, 2 and 3 is shown by the following method comparison studies.
Method Comparison
Serum, plasma, urine and CSF were collected from adult patients and assayed using HiChem® and Beckman® calibrators, reagents and wash solutions on a SYNCHRON CX® DELTA System. Results were compared by least squares linear regression and the following statistics were obtained.
| Analyte | Specimen | Unit | Regression Statistics | Summary Statistics | |||||
|---|---|---|---|---|---|---|---|---|---|
| n | a | b | r | range | mean X | mean Y | |||
| Calcium | Serum/Plasma | mg/dL | 160 | 0.0 | 0.989 | 0.985 | 7.1 - 10.6 | 9.26 | 9.13 |
| Urine | mg/dL | 74 | -0.2 | 1.007 | 0.998 | 2.4 - 15.2 | 8.45 | 8.3 | |
| Chloride | Serum/Plasma | mmol/L | 160 | 1.0 | 0.988 | 0.935 | 98.2 - 127.5 | 107.3 | 107.0 |
| Urine | mmol/L | 78 | -5.1 | 1.049 | 0.999 | 22.4 - 289 | 126.8 | 127.9 | |
| CSF | mmol/L | 44 | -3.4 | 1.024 | 0.985 | 113.8 - 152.4 | 126.5 | 126.1 | |
| Potassium | Serum/Plasma | meq/L | 160 | 0.13 | 0.969 | 1.000 | 3.20 - 10.82 | 5.02 | 5.00 |
| Urine | meq/L | 80 | 0.01 | 0.993 | 1.000 | 3.48 - 136.0 | 50.5 | 50.2 | |
| Sodium | Serum/Plasma | meq/L | 160 | 9.1 | 0.930 | 0.938 | 131.8 - 159.1 | 141.0 | 140.3 |
| Urine | meq/L | 78 | -0.3 | 1.000 | 1.000 | 16.9 - 288.1 | 118.2 | 117.8 | |
| Total CO2 | Serum/Plasma | mmol/L | 160 | 1.2 | 0.949 | 0.953 | 9.5 - 29.1 | 23.3 | 23.2 |
| BUN | Serum/Plasma | mgN/dL | 160 | -0.3 | 0.987 | 0.999 | 4 - 126 | 19.0 | 18.4 |
| Urine | mgN/dL | 79 | 0.9 | 0.979 | 1.000 | 6 - 142 | 76.2 | 75.4 | |
| Glucose | Serum/Plasma | mg/dL | 159 | -1.2 | 1.011 | 0.999 | 29 - 341 | 100.7 | 100.6 |
| Urine | mg/dL | 81 | -2.1 | 1.012 | 0.999 | 1 - 359 | 197.3 | 197.4 | |
| CSF | mg/dL | 45 | 1.0 | 0.973 | 0.999 | 3 - 186 | 81.9 | 80.7 | |
| Creatinine | Serum/Plasma | mg/dL | 160 | 0.0 | 0.991 | 0.997 | 0.4 - 5.4 | 1.09 | 1.08 |
| Urine | mg/dL | 79 | -0.3 | 1.000 | 1.000 | 12.1 - 309.2 | 112.5 | 112.3 |
Wynn Stocking
Wynn Stocking Manager of Regulatory Affairs Elan Diagnostics
20 August, 1999
510(k) Notification, HiChem® Calibrators 1, 2 & 3, page 81 is a division of Elan Pharmaceuticals
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 8 1999
Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 231 North Puente Street Brea. California 92821
Re: K992845
Trade Name: HiChem® Calibrator 1 Kit, Calibrator 2 Kit and Calibrator 3 Kit Regulatory Class: II Product Code: JIX Dated: August 20, 1999 Received: August 24, 1999
Dear Mr. Stocking:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Names:
HiChem® Calibrator 1 Kit, HiChem® Calibrator 2 Kit, and HiChem® Calibrator 3 Kit
Indications for Use:
HiChem® Calibrators 1, 2 and 3 are intended to calibrate the Beckman® SYNCHRON CX® DELTA and CX® CE® Systems for the quantitative determination of sodium, potassium, chloride, urea, giucose, creatinine, calcium and total CO2.
HiChem® Calibrators 1, 2 and 3 for the SYNCHRON CX® DELTA and CX® CE® Systems are intended to establish points of reference that are used in the determination of values in the measurement of substances in specimens.
These calibrators are intended for professional use only.
Respectfully,
Wynn Stocking
Wynn Stocking Regulatory Affairs Manager Elan Diagnostics
20 August, 1999
Sean Cooper
(Division Si
Division of Ciracal I shoratory Levices
510(k) Numb K992845
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
510(k) Notification, HiChem® Calibrators 1, 2 & 3 Elan Diagnostics, Brea, California
20 August, 1999 page 85 of 85