(61 days)
The FastPack® Total Testosterone Calibrator is intended to calibrate the FastPack® Analyzer system when used for the quantitative determination of testosterone in human serum.
Not Found
The provided document is a 510(k) summary for the FastPack® Testosterone Calibrator. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive performance studies with specific acceptance criteria in the way you've outlined for diagnostic algorithms.
Therefore, much of the requested information (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets, and training set sample sizes) is not present in this document because it describes a calibrator, not a diagnostic algorithm.
However, I can extract information related to the acceptance criteria for a calibrator and the general comparison made to the predicate device.
Here's the information that can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
For a calibrator, "acceptance criteria" and "device performance" are typically related to how well it functions within the assay system to yield accurate results, and how its characteristics compare to a predicate calibrator. The document doesn't explicitly state quantitative acceptance criteria for performance metrics like accuracy or precision of the calibrator itself but rather details its features and intended use in comparison to the predicate.
| Feature / Acceptance Criteria (Implied) | FastPack® Testosterone Calibrator Performance (Reported) |
|---|---|
| Intended Use | Calibrate the FastPack® Analyzer system for quantitative determination of testosterone in human serum. |
| Analyte Matrix | Total Testosterone, Buffered Bovine Serum Albumin |
| Form | Liquid |
| Volume | 2.5 mL |
| Levels | 1 |
| Substantial Equivalence | Determined by FDA; indicates functional similarity to the predicate device for its intended use as a calibrator. |
Study that proves the device meets the acceptance criteria:
The document doesn't describe a detailed performance study with quantitative results to prove specific acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device, the Diagnostic Products Corporation's Coat-A-Count Total Testosterone RIA Kit (K844423) Calibrator component. The 510(k) process for calibrators primarily involves showing that the new device has the same intended use and similar technological characteristics, or different characteristics that do not raise new questions of safety and effectiveness.
The "study" in this context is the submission of information to the FDA demonstrating that the FastPack® Testosterone Calibrator is sufficiently similar to the predicate device to be considered safe and effective for its stated intended use. This is supported by the "Comparison to Predicate Device" table provided in the document.
Missing Information (Not Applicable or Not Provided in this Document):
The following information is either not applicable to a calibrator's 510(k) submission as directly as it would be for a diagnostic algorithm, or it is simply not detailed in this specific document:
- 2. Sample size used for the test set and the data provenance: Not provided, as there isn't a "test set" in the sense of patient data for evaluating an algorithm's diagnostic performance. The comparison is between the calibrators' intrinsic properties and use.
- 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth as typically defined for diagnostic performance is not relevant for a calibrator.
- 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, as this is a calibrator, not an AI-powered diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
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KO22533
SEP 3 0 2002
510(k) Summary
FastPack® Testosterone Calibrator
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| 1. | Submittername,address,contact | Qualigen, Incorporated2042 Corte del NogalCarlsbad, CA 92009 | |
|---|---|---|---|
| Telephone:Fax: | (760) 918-9165(760) 918-9127 | ||
| Contact Person: | Dorothy Deinzer | ||
| Date Prepared: | July 23, 2002 | ||
| 2. | Devicename | Proprietary name: | FastPack® Testosterone Calibrator |
| Common name: | Calibrator | ||
| Classification Name: | Calibrator, Secondary | ||
| 3. | Predicatedevice | Diagnostic Products Corporation's Coat-A-Count Total TestosteroneRIA Kit (K844423), Calibrator component | |
| 4. | Intendeduse | The FastPack® Total Testosterone Calibrator is intended to calibratethe FastPack® Analyzer system when used for the quantitativedetermination of testosterone in human serum. |
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- The following table compares the FastPack® Testosterone 5. Comparison to Calibrator with the calibrator component of the DPC Coat-A-Predicate Count® Total Testosterone: Device
| Feature | FastPack®TestosteroneCalibrator | DPC Coat-A-Count,Calibrator Component |
|---|---|---|
| Intended Use | For calibration of theFastPack® Analyzersystem when used forthe quantitativedetermination oftestosterone in humanserum. | The testosterone calibratoris intended to prepare thestandard curve for the DPCCoat-A-Count assay kit fordetermination of totaltestosterone in human serumor heparinized plasma. |
| AnalyteMatrix | Total TestosteroneBuffered Bovine Serumalbumin | Total TestosteroneHuman serum – based |
| Form | Liquid | Liquid |
| Volume | 2.5 mL | 0 level, 4.0 mLOther levels, 1.0 mL |
| Levels | 1 | 6 |
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes emanating from its head, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper perimeter of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Dorothy Deinzer Director of Quality Assurance and Regulatory Affairs Qualigen, Inc. 2042 Corte Del Nogal Carlsbad, CA 92009
SEP 3 0 2002
Re: K022533
Trade/Device Name: FastPack® Testosterone Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: July 30, 2002 Received: July 31, 2002
Dear Ms. Deinzer:
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 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 (OS) 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 ' 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/cdrlv/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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Attachment 4
Indications for Use Statement
| 510(k) Number | K022533 |
|---|---|
| Device Name | FastPack® Testosterone Calibrator |
| Indications for Use | The FastPack® Testosterone Calibrator is intended to calibrate the FastPack® Analyzer system when used for the quantitative determination of Testosterone in human serum. |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Acan Copy
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022533
Prescription Use _
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _
§ 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.