(38 days)
For use as a calibrator of clinical chemistry assays. Biological materials are added as required to obtain desired component levels. This calibrator material is well suited for automated analytical procedures. Levels of constituent analytes are provided in product labeling.
The Calibrator for Automated Systems (C.f.a.s.) consists of lyophilized human serum with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in product labeling.
The provided text is a 510(k) summary for a medical device called "Calibrator for Automated Systems (C.f.a.s.)". This document is a regulatory submission for a diagnostic calibrator, not an AI device or a device that directly interacts with human readers for diagnostic purposes. Therefore, many of the requested criteria, such as "acceptance criteria and reported device performance" in the context of clinical accuracy for an AI, "sample size for the test set," "number of experts used," "adjudication method," "MRMC study," and "standalone performance," are not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against a specific set of acceptance criteria in the way one might for a new diagnostic test's accuracy.
However, based on the information provided, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
This type of comprehensive table with quantitative acceptance criteria and corresponding reported device performance with metrics like sensitivity, specificity, accuracy, etc., is not provided in this 510(k) summary. The summary focuses on comparing characteristics and intended use to a predicate device to establish substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not applicable and not provided. The device is a calibrator, and its "performance" is assessed through its characteristics and intended use, not clinical test set performance in a diagnostic sense.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth in the context of diagnostic accuracy for a clinical test is not established for a calibrator in this manner. The "truth" for a calibrator refers to the known concentrations of analytes, which are established through analytical methods, not expert consensus.
4. Adjudication method for the test set:
Not applicable.
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 device is a calibrator, not an AI or a device designed to assist human readers in image interpretation or diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
For a calibrator, the "ground truth" would be the analyte concentrations established through reference methods and internal quality control procedures during the manufacturing and characterization of the calibrator material. The document states: "Values for constituent analytes are provided in product labeling." This implies that the manufacturer determines these values.
8. The sample size for the training set:
Not applicable. This is a physical calibrator product, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what is applicable from the provided text regarding "acceptance criteria" (understood as characteristics deemed acceptable for substantial equivalence):
The "acceptance criteria" here are implicitly tied to the characteristics of the predicate device for demonstrating substantial equivalence. The study implicitly proving these "criteria" are met is the comparison to the predicate device itself.
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (C.f.a.s.) |
|---|---|
| Intended Use: For use as a calibrator of clinical chemistry assays, generally for automated analytical procedures. | For use as a calibrator of clinical chemistry assays for automated analytical procedures. |
| Format: Lyophilized pooled human serum with constituents added as required to obtain desired component levels. | Lyophilized pooled human sera with constituents added as required to obtain desired component levels. |
| Stability: Stable at 2-8 °C until expiration date. Stable 2 days when reconstituted, stoppered, protected from light and stored at 2-8° C, with exceptions. | Stable at 2-8 °C until expiration date. Stable 2 days when reconstituted, stoppered, protected from light and stored at 2-8° C, with exceptions noted in labeling. |
| Levels: Single Level | Single Level |
| Constituent Analytes: A specific list of analytes (e.g., Acid Phosphatase, Albumin, Glucose, Sodium, Potassium, etc.) | Matches the predicate device's list of analytes, plus additional analytes (Sodium, Potassium, Chloride, Bicarbonate, UIBC, LD1). This is noted as a "difference" but deemed acceptable for substantial equivalence. |
Study Proving Device Meets "Acceptance Criteria" (Substantial Equivalence):
The "study" is the comparison to the predicate device, Roche Serum Calibrator, as outlined in the 510(k) submission. The FDA reviewed this comparison and determined that the C.f.a.s. is substantially equivalent. This means that, based on the characteristics listed, the new device is considered as safe and effective as the predicate device. The detailed analytical methods used to characterize the analyte values and stability of both the predicate and proposed calibrator are not detailed in this summary but would be part of the full submission that the FDA reviewed.
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510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| Submitter name, address, contact | Roche Diagnostics Corporation 9115 Hague Rd Indianapolis, IN 46250 (317) 576-3723Contact person: Priscilla A. HamillDate prepared: February 10, 1999 |
| Device name | Proprietary name: Calibrator for Automated Systems (C.f.a.s.)Common name: C.f.a.s.Classification name: Calibrator, Multi-analyte mixture |
| Predicate device | We claim substantial equivalence to Roche Serum Calibrator. |
| Device description | The Calibrator for Automated Systems (C.f.a.s.) consists of lyophilized human serum with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in product labeling. |
| Intended use | The Calibrator for Automated Systems (C.f.a.s.) is intended for use as a calibrator of clinical chemistry assays. The material is well suited for automated analytical procedures. |
| Comparison tothe predicatedevice | The Calibrator for Automated Systems (C.f.a.s.) calibrator is substantiallyequivalent to other products in commercial distribution intended for similaruse. Most notably, it is substantially equivalent to the currently marketedRoche Serum Calibrator. |
| The intended use of this calibrator and the predicate devices is the same inthat they are intended to be used for the calibration of test systems for themeasurement of their labeled analytes. | |
| Substantialequivalence --similarities | The chart below illustrates the similarities between Calibrator for AutomatedSystems (C.f.a.s.)and the predicate device. |
Continued on next page
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510(k) Summary, Continued
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:
Comparison of predicate device and proposed Calibrator for Automated Systems (C.f.a.s.)
| Characteristic | C.f.a.s.(Modified Device) | Roche Calibrator Serum(Predicate Device) |
|---|---|---|
| Intended Use | For use as a calibrator of clinical chemistry assays for automated analytical procedures. | For use on COBAS systems and manual determinations with Roche reagents to establish points of reference |
| Format | Lyophilized pooled human sera with constituents added as required to obtain desired component levels | Lyophilized pooled human serum with constituents added as required to obtain desired component levels |
| Stability | Stable at 2-8 °C until expiration date Stable 2 days when reconstituted, stoppered, protected from light and stored at 2-8° C, with exceptions noted in labeling. | Stable at 2-8 °C until expiration date Stable 2 days when reconstituted, stoppered, protected from light and stored at 2-8° C, with exceptions noted in labeling. |
| Levels | Single Level | Single Level |
and the comments of the comments of
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K9.90460
Substantial equivalence -differences
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Comparison of predicate device and proposed Calibrator for Automated Systems (C.f.a.s.) .
Constituent Analytes
| C.f.a.s. (Modificed Device) | Roche Calibrator Serum(Predicate Device) |
|---|---|
| Acid Phosphatase | Acid Phosphatase |
| Alkaline Phosphatase | Alkaline Phosphatase |
| Alanine Aminotransferase | Alanine Aminotransferase |
| α-Amylase | α-Amylase |
| Aspartate Aminotransferase | Aspartate Aminotransferase |
| Cholinesterase | Cholinesterase |
| Creatine Kinase | Creatine Kinase |
| y-Glutamyltransferase | y-Glutamyltransferase |
| Lactate Dehydrogenase | Lactate Dehydrogenase |
| Lipase | Lipase |
| Albumin | Albumin |
| Bilirubin (Direct) | Bilirubin (Direct) |
| Bilirubin (Total) | Bilirubin (Total) |
| Calcium | Calcium |
| Cholesterol | Cholesterol |
| Creatinine | Creatinine |
| Glucose | Glucose |
| Iron | Iron |
| Magnesium | Magnesium |
| Phosphorus (Inorganic) | Phosphorus (Inorganic) |
| Total Protein | Total Protein |
| Triglycerides | Triglycerides |
| Uric Acid | Uric Acid |
| Urea (BUN) | Urea (BUN) |
| Sodium | |
| Potassium | |
| Chloride | |
| Bicarbonate | |
| UIBC | |
| LD1 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
MAR 2 2 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Priscilla A. Hamill Requlatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K990460 Trade Name: Calibrator for Automated Systems (C.f.a.s.) Requlatory Class: II Product Code: JIX Dated: February 10, 1999 Received: February 12, 1999
Dear Ms. Hamill:
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, Druq, 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 (QS) 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. this response to your premarket notification Please note: submission does not affect any obliqation 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.
Image /page/3/Picture/9 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
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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 Sutman
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
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Calibrator for Automated Systems (C.f.a.s.)
Indications for Use:
For use as a calibrator of clinical chemistry assays. Biological materials are added as required to obtain desired component levels. This calibrator material is well suited for automated analytical procedures. Levels of constituent analytes are provided in product labeling.
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Review
Division of Clinical Laboratory Devices K990460 510(k) Number_
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED)
NdBDDD)
---------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (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.