(20 days)
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.
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 provided document describes the ATAC Calibrator Kit and its performance in demonstrating substantial equivalence to a predicate device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria for the regression statistics (e.g., specific ranges for slope and y-intercept). However, the implicit acceptance criterion is that the regression statistics demonstrate substantial equivalence to the comparative method, indicating accurate calibration.
| Analyte | Comparative Method | Reported Device Performance (Regression Statistics) |
|---|---|---|
| Albumin | Hitachi 704 / Roche Albumin Reagent, product 1970569Roche c.f.a.s Calibrator, product 759350 | y = 0.25 + 0.908x, n = 59 |
| Magnesium | Beckman Synchron CX Magnesium Reagent, product 445360Beckman Synchron Multi Calibrator, product 442600 | y = 0.03 + 0.967x, n = 55 |
| Phosphorus | Beckman Synchron CX Phosphorus Reagent, product 465145Beckman Synchron Multi Calibrator, product 442600 | y = - 0.10 + 0.992x, n = 58 |
| Total Bilirubin | Beckman Synchron CX Total Bilirubin Reagent, product 442745Beckman Synchron Bilirubin Calibrator, product 465915 | y = - 0.06 + 1.031x, n = 54 |
| Total Protein | Beckman Synchron CX Total Protein Reagent, product 442740Beckman Synchron Multi Calibrator, product 442600 | y = 0.00 + 1.000x, n = 52 |
Additionally, for reconstituted stability:
- Acceptance Criteria (Implicit): Statistically insignificant changes or changes less than round-off error/minimal clinical significance.
- Reported Device Performance:
- Changes in 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.
- Observed change for phosphorus over three days was less than 0.2 mg/dL.
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size:
- Albumin: 59 sera
- Magnesium: 55 sera
- Phosphorus: 58 sera
- Total Bilirubin: 54 sera
- Total Protein: 52 sera
- Data Provenance: The data provenance is not explicitly stated (e.g., country of origin). The studies appear to be prospective in nature, as they involve assaying "at least 50 sera" for comparison with existing methods. It does not indicate the data is retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of study does not involve "experts" establishing ground truth in the way a medical imaging study might. Instead, the "ground truth" for the calibrator's performance is established by comparing its calibration results to those obtained using established, commercially available comparative methods with their respective calibrators and reagents. The document does not specify the qualifications of the individuals who performed these laboratory assays, but it would typically be trained laboratory personnel.
4. Adjudication Method for the Test Set
Not applicable. This is a quantitative laboratory calibration study comparing results to established methods, not a subjective interpretation task requiring adjudication by multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
Not applicable. This is a calibration study for an in vitro diagnostic device, not a study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this study essentially demonstrates the "standalone" performance of the ATAC Calibrator Kit in the context of the ATAC 8000 Random Access Chemistry System. It assesses the calibrator's accuracy by comparing results from the ATAC system (calibrated with the ATAC Calibrator) against established laboratory methods.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used is the results obtained from established, commercially available comparative methods (e.g., Hitachi 704, Beckman Synchron CX reagents) which themselves are calibrated with their respective, validated calibrators. This serves as the reference standard for evaluating the accuracy of the ATAC Calibrator Kit.
8. The Sample Size for the Training Set
Not applicable. This is a calibration and method comparison study, not a machine learning study that typically involves distinct training and test sets in the same way. The calibrator itself (ATAC Calibrator Kit) is used to establish reference points, and its accuracy is then validated against other calibrated methods. There isn't an "algorithm" being trained in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there isn't a "training set" in the context of a machine learning algorithm. The "ground truth" for the overall system's performance is established by the well-defined, validated methodologies of the comparative reference instruments and reagents.
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MAR 1 9 2003
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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 1970569Roche c.f.a.s Calibrator, product 759350 | y = 0.25 + 0.908x, n = 59 |
| Magnesium | Beckman Synchron CX Magnesium Reagent, product 445360Beckman Synchron Multi Calibrator, product 442600 | y = 0.03 + 0.967x, n = 55 |
| Phosphorus | Beckman Synchron CX Phosphorus Reagent, product 465145Beckman Synchron Multi Calibrator, product 442600 | y = - 0.10 + 0.992x, n = 58 |
| TotalBilirubin | Beckman Synchron CX Total Bilirubin Reagent, product 442745Beckman Synchron Bilirubin Calibrator, product 465915 | y = - 0.06 + 1.031x, n = 54 |
| Total Protein | Beckman Synchron CX Total Protein Reagent, product 442740Beckman 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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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
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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)
§ 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.