(20 days)
465915
Not Found
No
The document describes a calibrator kit for clinical chemistry tests, focusing on chemical analysis and calibration procedures. There is no mention of AI, ML, or any computational methods beyond standard statistical analysis for performance evaluation.
No
The device is a calibrator kit used for in vitro diagnostic testing to establish reference points for quantitative determination of various substances in human specimens, not for directly treating a condition or disease.
No
This device is a calibrator kit used to establish reference points for ATAC Clinical Systems, which then determine levels of various substances in human specimens. It does not directly diagnose conditions itself.
No
The device description explicitly states it is a "Calibrator Kit" and describes its use with "reagent applications," indicating it is a physical product containing reagents, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "determination of albumin, calcium, cholesterol, creatinine, glucose, magnesium, phosphorus, total bilirubin, total protein and urea in human specimens." This involves testing biological samples (human specimens) outside of the body to provide information about a person's health.
- Device Description: The device description confirms its purpose is to "calibrate the ATAC Clinical Systems for the quantitative determination of..." various analytes in human specimens. Calibration is a crucial step in ensuring the accuracy of IVD tests.
- Professional Setting: The intended user is "trained personnel in a professional setting," which is typical for IVD devices used in laboratories or clinical environments.
- Performance Studies: The document includes a summary of performance studies, which are required for IVD devices to demonstrate their accuracy and reliability.
- Predicate Device: The mention of a "Predicate Device" (Beckman Synchron Multi-Calibrator) is common in regulatory submissions for IVD devices, where a new device is compared to an already approved one.
All of these factors strongly indicate that the ATAC Calibrator Kit is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ATAC Calibrator Kit is intended for use with the ATAC Clinical Systems to establish points of reference that are used in the determination of albumin, calcium, cholesterol, creatinine, glucose, magnesium, phosphorus, total bilirubin, total protein and urea in human specimens.
Product codes
JIX
Device Description
The ATAC Calibrator Kit is intended to calibrate the ATAC Clinical Systems for the quantitative determination of albumin, calcium, cholesterol, creatinine, glucose, magnesium, phosphorus, total protein and urea nitrogen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
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
The reconstituted stability claim is confirmed through the assay of albumin, total bilirubin and total protein in calibrators of increasing ages. The observed changes in the concentrations of albumin, magnesium, bilirubin and total protein over 3 days at 2°C to 8°C were statistically insignificant or less than the round-off error of the assay. The observed change for phosphorus over three days was less than 0.2 mg/dL.
The accuracy of the assigned set points was documented through method comparison studies. At least 50 sera were assayed for albumin, magnesium, phosphorus, total bilirubin and total protein over at least 4 analytical runs using a commercially available method and ATAC reagent applications calibrated with the ATAC Calibrator.
The following Deming regression statistics are provided:
- Analyte: Albumin, Comparative Method: Hitachi 704 / Roche Albumin Reagent, product 1970569 Roche c.f.a.s Calibrator, product 759350, Regression Statistics: y = 0.25 + 0.908x, n = 59
- Analyte: Magnesium, Comparative Method: Beckman Synchron CX Magnesium Reagent, product 445360 Beckman Synchron Multi Calibrator, product 442600, Regression Statistics: y = 0.03 + 0.967x, n = 55
- Analyte: Phosphorus, Comparative Method: Beckman Synchron CX Phosphorus Reagent, product 465145 Beckman Synchron Multi Calibrator, product 442600, Regression Statistics: y = - 0.10 + 0.992x, n = 58
- Analyte: Total Bilirubin, Comparative Method: Beckman Synchron CX Total Bilirubin Reagent, product 442745 Beckman Synchron Bilirubin Calibrator, product 465915, Regression Statistics: y = - 0.06 + 1.031x, n = 54
- Analyte: Total Protein, Comparative Method: Beckman Synchron CX Total Protein Reagent, product 442740 Beckman Synchron Multi Calibrator, product 442600, Regression Statistics: y = 0.00 + 1.000x, n = 52
Key Metrics
Not Found
Predicate Device(s)
Beckman Synchron Multi-Calibrator, product no. 465915
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
MAR 1 9 2003
Image /page/0/Picture/1 description: The image shows the word "élan" in a stylized font. The "é" has a unique design, with the top part of the letter replaced by a textured, gradient-like effect that resembles a burst or spray. The rest of the letters are in a simple, sans-serif font, creating a contrast between the artistic "é" and the more straightforward "lan".
1075 W. Lambert Road Building D Brea, California 92821 T (714) 672 3553 F (714) 672 3554
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.
The ATAC Calibrator Kit is intended to calibrate the ATAC Clinical Systems for the quantitative determination of albumin, calcium, cholesterol, creatinine, glucose, magnesium, phosphorus, total protein and urea nitrogen. The ATAC Calibrator is substantially equivalent to the Beckman Synchron Multi-Calibrator, product no. 465915, which is currently marketed by Beckman Coulter, Inc. of Brea, CA. The effectiveness of ATAC Calibrator Kit on the ATAC 8000 Random Access Chemistry System is shown by the following studies.
The reconstituted stability claim is confirmed through the assay of albumin, total bilirubin and total protein in calibrators of increasing ages. The observed changes in the concentrations of albumin, magnesium, bilirubin and total protein over 3 days at 2°C to 8°C were statistically insignificant or less than the round-off error of the assay. The observed change for phosphorus over three days was less than 0.2 mg/dL.
The accuracy of the assigned set points was documented through method comparison studies. At least 50 sera were assayed for albumin, magnesium, phosphorus, total bilirubin and total protein over at least 4 analytical runs using a commercially available method and ATAC reagent applications calibrated with the ATAC Calibrator.
| Analyte | Comparative Method | Regression Statistics |
|---|---|---|
| Albumin | Hitachi 704 / Roche Albumin Reagent, product 1970569 | |
| Roche c.f.a.s Calibrator, product 759350 | y = 0.25 + 0.908x, n = 59 | |
| Magnesium | Beckman Synchron CX Magnesium Reagent, product 445360 | |
| Beckman Synchron Multi Calibrator, product 442600 | y = 0.03 + 0.967x, n = 55 | |
| Phosphorus | Beckman Synchron CX Phosphorus Reagent, product 465145 | |
| Beckman Synchron Multi Calibrator, product 442600 | y = - 0.10 + 0.992x, n = 58 | |
| Total | ||
| Bilirubin | Beckman Synchron CX Total Bilirubin Reagent, product 442745 | |
| Beckman Synchron Bilirubin Calibrator, product 465915 | y = - 0.06 + 1.031x, n = 54 | |
| Total Protein | Beckman Synchron CX Total Protein Reagent, product 442740 | |
| Beckman Synchron Multi Calibrator, product 442600 | y = 0.00 + 1.000x, n = 52 |
Deming regression statistics are summarized below.
Wyman Stoching
n Stocking Manager of Regulatory Affairs Elan, Brea California
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1
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 9 2003
Mr. Wynn Stocking Manager of Regulatory Affairs Elan Diagnostics 1075 W. Lambert Road Building D Brea, California 92821
Re: K030621
Trade/Device Name: ATAC Calibrator Kit Regulation Number: 21 CFR § 862.1150 Regulation Name: Calibrator, Multi - Analyte Mixture Regulatory Class: II Product Code: JIX Dated: February 26, 2003 Received: February 27, 2003
Dear Mr. Stocking:
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 (OS) regulation (21 CFR Part 820). 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.
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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 Sutman
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
3
510(k) Number (if known):
Device Name:
ATAC Calibrator
Indications for Use:
The ATAC Calibrator Kit is intended for use with the ATAC Clinical Systems to establish points of reference that are used in the determination of albumin, calcium, cholesterol, creatinine, glucose, magnesium, phosphorus, total bilirubin, total protein and urea in human specimens.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K030624
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)