(61 days)
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No
The document describes a calibrator for a testosterone assay, which is a chemical reagent, not a software or imaging device typically associated with AI/ML. There are no mentions of AI, ML, image processing, or performance metrics related to algorithmic analysis.
No
The device is a calibrator for a system that quantitatively determines testosterone levels, which is a diagnostic function, not a therapeutic one.
Yes
The device is a calibrator for a system that quantitatively determines testosterone, and its predicate device is a diagnostic kit. This indicates its role in ensuring the accuracy of diagnostic measurements.
No
The device is a calibrator for an analyzer system, which implies a physical component used in a laboratory setting, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of testosterone in human serum." This involves testing a biological sample (human serum) outside of the body (in vitro) to diagnose or monitor a condition (testosterone levels).
- Device Type: It's a "Calibrator" for an "Analyzer system" used for this determination. Calibrators are essential components of many IVD systems, used to ensure the accuracy of the measurements.
- Predicate Device: The predicate device listed is a "Total Testosterone RIA Kit, Calibrator component." This further confirms that this type of device is classified as an IVD.
The definition of an IVD generally includes reagents, calibrators, control materials, kits, instruments, apparatus, equipment, or systems intended for use in the in vitro examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits squarely within this definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
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. | Submitter
name,
address,
contact | Qualigen, Incorporated
2042 Corte del Nogal
Carlsbad, CA 92009 | |
|----|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| | Telephone:
Fax: | (760) 918-9165
(760) 918-9127 | |
| | Contact Person: | Dorothy Deinzer | |
| | Date Prepared: | July 23, 2002 | |
| 2. | Device
name | Proprietary name: | FastPack® Testosterone Calibrator |
| | | Common name: | Calibrator |
| | | Classification Name: | Calibrator, Secondary |
| 3. | Predicate
device | Diagnostic Products Corporation's Coat-A-Count Total Testosterone
RIA Kit (K844423), Calibrator component | |
| 4. | Intended
use | The FastPack® Total Testosterone Calibrator is intended to calibrate
the FastPack® Analyzer system when used for the quantitative
determination of testosterone in human serum. | |
1
- 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®
Testosterone
Calibrator | DPC Coat-A-Count,
Calibrator Component |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For calibration of the
FastPack® Analyzer
system when used for
the quantitative
determination of
testosterone in human
serum. | The testosterone calibrator
is intended to prepare the
standard curve for the DPC
Coat-A-Count assay kit for
determination of total
testosterone in human serum
or heparinized plasma. |
| Analyte
Matrix | Total Testosterone
Buffered Bovine Serum
albumin | Total Testosterone
Human serum – based |
| Form | Liquid | Liquid |
| Volume | 2.5 mL | 0 level, 4.0 mL
Other levels, 1.0 mL |
| Levels | 1 | 6 |
2
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.
3
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
4
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 _