(27 days)
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Not Found
No
The document describes a calibrator, which is a reference material used in clinical chemistry. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the calibrator's function as a reference material for single-point calibration.
No
The document states the device is for the calibration of clinical chemistry assays and is intended for use as a reference material. It does not directly treat or diagnose patients.
No
The device is a calibrator, intended to be used in the calibration of clinical chemistry assays, not to diagnose a disease or condition itself.
No
The device is described as a "reference material" and a "calibrator," which are physical substances used in laboratory procedures, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "calibration of clinical chemistry assays." Clinical chemistry assays are performed on biological samples (like blood or urine) in vitro (outside the body) to diagnose or monitor medical conditions.
- Device Description: The description reinforces its use as a "reference material in the single point calibration of clinical chemistry procedures." Reference materials used for calibrating in vitro diagnostic tests are themselves considered IVDs.
The fact that it's used to calibrate other IVDs makes it an IVD itself, as it's an accessory or component essential for the proper functioning and accuracy of those diagnostic tests.
N/A
Intended Use / Indications for Use
Thermo DMA's Data-Cal is intended for use as a reference material in the single point calibration of clinical chemistry procedures.
The Thermo DMA Data-Cal Calibrator is intended for use in the calibration of clinical chemistry assays.
Product codes
JIX
Device Description
Thermo DMA Data-Cal Calibrator is to be used in clinical chemistry assays where it reacts in a manner equivalent to corresponding components present in serum samples.
Pooled human sera with constituents added as required to obtain levels.
Single level
Lyophilized
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Protocol for accelerated stability: [See Table I - Stability Data] The product was put at 37°C for 21.5 days. According to the Thermo DMA SOP for Accelerated Stability Testing (SOP #20) this time period is equivalent to 36 months when stored at 2-8° C. After the accelerated storage interval the calibrator was reconstituted and compared to material that had been stored at 2-8° C. Both the stressed and non-stressed materials were then assayed seven days after reconstitution to validate the proposed reconstitution stability claim. In addition to this accelerated evaluation the manufacturer of the calibrator material has documented real time stability data for calibrators of equivalent composition.
Process for value assignment and validation: The values were assigned for this calibrator by assaying the calibrator as unknowns in analyte specific reagents. The assays were calibrated against NIST primary standards where available. In order to insure that vial-to-vial variability was properly evaluated, duplicate tests were run on ten vials. Results obtained in this evaluation were consistent with those obtained in testing conducted on equivalent predicate devices.
Instruments and statistical analysis: [See Table II - Set Points] For purposes of obtaining data for this protocol Thermo DMA conducted tests using standard procedures applicable to the Roche Hitachi 717 to generate analyte values. Each unknown was assayed in two separate runs using different lot numbers of reagents. These unknowns were run after they had been stored at 2-8° C and at 37°C. The analyte set points for the calibrator were determined by calculating the mean value of twenty replicates. When subsequent calibrator lots are produced for market distribution, testing will be conducted utilizing multiple analyzers.
Traceability: The analyte values obtained are traceable to NIST material where available. Primary standards were incorporated into testing protocols in order to support accuracy and traceability. These Primary Standards were produced in house utilizing NIST Standard Reference Materials (SRM) in accordance with procedures provided by NIST.
Where NIST SRW's were not available for use in testing, standards were prepared using high purity materials in accordance with established clinical chemistry analytical procedures. These secondary methods have an established history of providing standards with known performance characteristics.
Performance transfer: [See Table III - Verification] In the case of each analyte the value of the secondary calibrator was determined by assaying it as an unknown sample while calibrating with a primary calibrator. After target values were established, the secondary calibrator was then used to calibrate an assay, which included a primary calibrator when possible. If no primary standard was available a calibrator from a vendor (Verichem, Inc.) that currently manufacturers and distributes similar products was incorporated into the assay protocol. All verification runs included a serum-based standard from Verichem to confirm that an accurate set point had been determined. Thermo DMA also included NIST SRM #909b into the testing protocols where appropriate. Our criteria when calibrating against the secondary calibrator was to obtain the set point for the SRM or Verichem within +/- 108. This criterion was met in all cases except for instances in which the value established fell below one, and in the case of Triglyceride SRM #909b, Level 1 which recovered 148. Thermo DMA feels that the triglyceride set point is valid due to the facts that the Verichem material recovers within 6% and the previous lot of calibrator recovers its established set point. Samples of the predicate calibrator were also included in test protocols, the results of which were consistent with historic performance data.
Conclusion: Analysis of the comparative measurements and stability data presented in the 510(k) submission for this calibrator, demonstrates the Thermo DMA Data-Cal Calibrator is safe and effective. No significant differences exist between the results obtained on tests conducted utilizing the Thermo DMA Data-Cal when compared to those obtained when utilizing the predicate device in these studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Data Medical Associates (DMA) Data-Cal
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.
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Thermo DMA
JUL 2 5 2002
845 Avenue G East Arlington, TX 76011-7709
(817) 607-1700 Fax: (817) 649-2461 www.thermodma.com
510 (k) Summary
This Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitter: Thermo DMA, Inc.
Address: 845 Avenue G East Arlington, Texas 76011
Contact Person: Thomas Dollar, Manager of Regulatory Affairs
The assigned 510 (k) number is
Product Code: JIX, Calibrator, Multi-Analyte Mixture
Device Name: Thermo DMA Data-Cal
Device Class: II
Predicate Device: Data Medical Associates (DMA) Data-Cal
Description and Intended Use: Thermo DMA's Data-Cal is intended for use as a reference material in the single point calibration of clinical chemistry procedures.
Clinical Significance :
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 serum specimens.
Methodology :
Thermo DMA Data-Cal Calibrator is to be used in clinical chemistry assays where it reacts in a manner equivalent to corresponding components present in serum samples.
Substantial Equivalence - Similarities:
| Feature | New calibrator | Current calibrator
(Predicate device) |
|--------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Intended Use | For the quantitative calibration
of clinical chemistry assays. | For the quantitative
calibration of clinical
chemistry assays. |
| Format | Pooled human sera with constituents
added as required to obtain levels. | Pooled human sera with
constituents added as
required to obtain levels. |
| Stability | Stable at 2-8 °C until expiration
expiration date. | Stable at 2-8 °C until
expiration date. |
| | Stable for seven days after
reconstitution. | Stable for five days after
reconstitution. |
Date of Preparation: June 26, 2002
Page 1 of 3
A Thermo Electron business
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| Feature | New calibrator | Current calibrator
(Predicate device) |
|----------------|----------------|------------------------------------------|
| Levels | single level | single level |
| Physical State | lyophilized | lyophilized |
Differences
There are no significant differences between the two products.
Protocol for accelerated stability: [See Table I - Stability Data]
The product was put at 37°C for 21.5 days. According to the Thermo DMA SOP for Accelerated Stability Testing (SOP #20) this time period is equivalent to 36 months when stored at 2-8° C. After the accelerated storage interval the calibrator was reconstituted and compared to material that had been stored at 2-8° C. Both the stressed and non-stressed materials were then assayed seven days after reconstitution to validate the proposed reconstitution stability claim. In addition to this accelerated evaluation the manufacturer of the calibrator material has documented real time stability data for calibrators of equivalent composition.
Samples of the calibrator material will be held for real time stability testing at Thermo DMA.
Process for value assignment and validation
The values were assigned for this calibrator by assaying the calibrator as unknowns in analyte specific reagents. The assays were calibrated against NIST primary standards where available. In order to insure that vial-to-vial variability was properly evaluated, duplicate tests were run on ten vials. Results obtained in this evaluation were consistent with those obtained in testing conducted on equivalent predicate devices.
Instruments and statistical analysis: [See Table II - Set Points]
For purposes of obtaining data for this protocol Thermo DMA conducted tests using standard procedures applicable to the Roche Hitachi 717 to generate analyte values. Each unknown was assayed in two separate runs using different lot numbers of reagents. These unknowns were run after they had been stored at 2-8° C and at 37°C. The analyte set points for the calibrator were determined by calculating the mean value of twenty replicates.
When subsequent calibrator lots are produced for market distribution, testing will be conducted utilizing multiple analyzers.
Traceability
The analyte values obtained are traceable to NIST material where available. Primary standards were incorporated into testing protocols in order to support accuracy and traceability. These Primary Standards were produced in house utilizing NIST Standard Reference Materials (SRM) in accordance with procedures provided by NIST.
Date of Preparation: June 26, 2002
2
Traceability - {continued)
Where NIST SRW's were not available for use in testing, standards were prepared using high purity materials in accordance with established clinical chemistry analytical procedures. These secondary methods have an established history of providing standards with known performance characteristics.
The following SRM materials were utilized in the production of Primary Standards employed;
| Analyte | SRM # |
|---|---|
| a. CO2 | SRM 192b |
| b. Bilirubin | SRM 916a |
| c. BUN | SRM 912a |
| d. Calcium | SRM 915a |
| e. Chloride | SRM 919a |
| f. Cholesterol | SRM 911b |
| g. Creatinine | SRM 914a |
| h. Glucose | SRM 917a |
| i. Iron | SRM 937 |
| j. Magnesium | SRM 929 |
| k. Phosphorus | SRM 186-I-f |
| l. Uric Acid | SRM 913 |
Performance transfer: [See Table III - Verification]
In the case of each analyte the value of the secondary calibrator was determined by assaying it as an unknown sample while calibrating with a primary calibrator. After target values were established, the secondary calibrator was then used to calibrate an assay, which included a primary calibrator when possible.
If no primary standard was available a calibrator from a vendor (Verichem, Inc.) that currently manufacturers and distributes similar products was incorporated into the assay protocol. All verification runs included a serum-based standard from Verichem to confirm that an accurate set point had been determined.
Thermo DMA also included NIST SRM #909b into the testing protocols where appropriate. Our criteria when calibrating against the secondary calibrator was to obtain the set point for the SRM or Verichem within +/- 108. This criterion was met in all cases except for instances in which the value established fell below one, and in the case of Triglyceride SRM #909b, Level 1 which recovered 148. Thermo DMA feels that the triglyceride set point is valid due to the facts that the Verichem material recovers within 6% and the previous lot of calibrator recovers its established set point. Samples of the predicate calibrator were also included in test protocols, the results of which were consistent with historic performance data.
Conclusion: Analysis of the comparative measurements and stability data presented in the 510(k) submission for this calibrator, demonstrates the Thermo DMA Data-Cal Calibrator is safe and effective. No significant differences exist between the results obtained on tests conducted utilizing the Thermo DMA Data-Cal when compared to those obtained when utilizing the predicate device in these studies.
Date of Preparation: June 26, 2002
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
.
Food and Drug Administration 2098 Gaither Road · Rockville MD 20850
Mr. Thomas Dollar Manager of Regulatory Affairs Thermo DMA 845 Avenue G East Arlington, TX 76011-7709
Re: K022108 Trade/Device Name: Thermo DMA Data-Cal Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: June 27, 2002 Received: June 28, 2002
Dear Mr. Dollar:
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.
JUL 2 5 2002
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
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 i 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Butman
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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INDICATIONS FOR USE STATEMENT