(25 days)
Not Found
No
The document describes a set of calibration and verification solutions for in vitro diagnostic testing, which are chemical reagents and do not incorporate AI/ML technology. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
This device is for in vitro diagnostic use to verify calibration and analytical ranges on clinical chemistry systems for salicylate and does not treat or prevent disease.
Yes
The "Intended Use / Indications for Use" states that the solutions are "intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification, verification of Analytical Measurement Range (AMR) and verification of the reportable range on immunochemistry and clinical chemistry systems for salicylate." This indicates its role in validating diagnostic systems.
No
The device is a set of solutions containing salicylate, which are physical substances, not software. The description clearly states it "consists of 5 levels of solutions".
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The DOCUMENT® Salicylate CAL•VER® solutions are intended for in vitro diagnostic use..."
- Device Description: The device is a set of solutions containing salicylate in a human serum matrix, designed to be used on immunochemistry and clinical chemistry systems. This aligns with the nature of IVD devices, which are used to examine specimens from the human body to provide information for diagnostic purposes.
- Intended User / Care Setting: It specifies "in vitro diagnostic use on immunochemistry and clinical chemistry systems," further reinforcing its IVD classification.
The purpose of these solutions is to verify the performance of diagnostic instruments used to measure salicylate levels in patient samples, which is a core function of IVD devices.
N/A
Intended Use / Indications for Use
The DOCUMENT® Salicylate CAL•VER® solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification, verification of Analytical Measurement Range (AMR) and verification of the reportable range on immunochemistry and clinical chemistry systems for salicylate. Multiple levels are provided to establish the linear relationship between theoretical operation and actual performance. There exists a linear relationship among each of the solutions.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The DOCUMENT® Salicylate CAL•VER® set consists of 5 levels of solutions containing salicylate - Levels 1 through 5 - with concentrations ranging between 0 to approximately 100 mg salicylate/dL. The base matrix for these solutions is human serum with preservatives added for stability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are 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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Ko41073
SECTION II
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number:
Submitter:
Microgenics Corporation 46360 Fremont Blvd Fremont, CA 94538 Telephone: (510)-979-5012 Facsimile: (510) 979-5212
Contact Person:
David Casal, Ph.D. Vice-President, Clinical, Regulatory and Quality Affairs Telephone: (510)-979-5012 Facsimile: (510) 979-5212
Preparation Date:
April21, 2004
Device Information:
| Device Classification Name: | Single (Specifi ed) Analyte Control (assayed and unassayed) |
|---|---|
| Device Description | Quality control material (assayed and unassayed) |
| Proprietary Name: | DOCUMENT® Salicylate CAL•VER® |
| Regulation Number: | 21 CFR§862.1660 |
| Product Code: | JJX |
| Regulatory Class: | Class I |
Predicate Devices:
Evaluation of the data and results enclosed herein demonstrate that the DOCUMENT® Salicylate CAL • VER® set is substantially equivalent in form and function to the DOCUMENT® Thyroid CAL • VER® set (K992034) for its stated intended use.
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Device Description:
The DOCUMENT® Salicylate CAL•VER® set consists of 5 levels of solutions containing salicylate - Levels 1 through 5 - with concentrations ranging between 0 to approximately 100 mg salicylate/dL. The base matrix for these solutions is human serum with preservatives added for stability.
Intended Use:
The DOCUMENT® Salicylate CAL•VER® solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification, verification of Analytical Measurement Range (AMR) and verification of the reportable range on immunochemistry and clinical chemistry systems for salicylate. Multiple levels are provided to establish the linear relationship between theoretical operation and actual performance. There exists a linear relationship among each of the solutions.
Comparison to Predicate Device(s):
The DOCUMENT® Salicylate CAL•VER® Kit is substantially equivalent to the DOCUMENT® Thyroid CAL• VER® (K992034), also manufactured by Microgenics (CASCO) and previously cleared by FDA, for its stated intended use.
| Device
| Characteristics | Subject Device | Predicate Device (K992034) |
|---|---|---|
| Intended Use | The DOCUMENT® Salicylate | |
| CAL•VER® solutions are intended for | ||
| in vitro diagnostic use in the | ||
| quantitative determination of linearity, | ||
| calibration verification, verification of | ||
| Analytical Measurement Range (AMR) | ||
| and verification of the reportable range | ||
| on immunochemistry and clinical | ||
| chemistry systems for salicylate. | ||
| Multiple levels are provided to | ||
| establish the linear relationship between | ||
| theoretical operation and actual | ||
| performance. There exists a linear | ||
| relationship among each of the | · DOCUMENT® Thyroid CAI · | |
| VER® contains assayed solutions for | ||
| in vitro diagnostic use in the | ||
| quantitative determination of linearity, | ||
| calibration verification and | ||
| verification of reportable range on | ||
| immunochemistry systems and | ||
| clinical chemistry systems for the | ||
| following analytes: Thyroxine (T4), | ||
| Triiodothyronine (T3) and Thyroid | ||
| Stimulating Hormone (TSH). This | ||
| product is not intended for use as a | ||
| calibration material on instrument | ||
| systems or as a routine quality control | ||
| solutions. | material. | |
| Analytes | ||
| (by configuration) | Salicylate | Thyroxine (T4), |
| Triiodothyronine (T3) | ||
| Thyroid Stimulating Hormone (TSH) | ||
| Matrix | Human Serum | Human Serum |
| Control Form | Liquid | Liquid |
| Control Levels | Five target levels ranging from 0 to | |
| approximately 100 mg/dL. | Eight levels across the reportable | |
| range | ||
| Storage | 2°C to 8°C until expiration date | 2℃ to 8℃ until expiration date |
| Stability | Until expiration date noted on vial | |
| label. | Until expiration date noted on vial | |
| label. |
Summary:
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The information provided in this pre-market notification demonstrates that the DOCUMENT® Salicylate CAL • VER® kit is substantially equivalent in form and function to the DOCUMENT® Thyroid CAL • VER® (K992034) for its stated intended use. Substantial equivalence was demonstrated through comparison of intended use and physical properties of the subject device to the commercially available predicate device. The information supplied in this pre-market notification provides reasonable assurance that DOCUMENT® Salicylate CAL • VER® kit is safe and effective for its stated intended use.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 1 2004
David Casal, Ph.D. Vice President, Clinical, Regulatory and Quality Affairs Microgenics Corp. 46360 Fremont Blvd. Fremont, CA 94538
K041073 Re:
Trade/Devicc Name: DOCUMENT® Salicylate CAL•VER® Kit Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: April 21, 2004 Received: May 10, 2004
Dear Dr. Casal:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreased of 76, the enactment date of the Medical Device Amendments, or to conimores prox to rial and in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, iteres, and on of the Act include requirements for annual registration, listing of general voltaren profice, 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 ean be found in ther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rouse be act not 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 or any I edolul statuates and 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 (QS) regulation (21 CFR Part 820).
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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 promated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, n fourstions 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,
Seavin M. Cooper, US, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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SECTION III
INDICATIONS FOR USE STATEMENT
Ko4107 ಿಗೆ 510(k) Number (if known):
DOCUMENT® Salicylate CAL•VER® Kit Device name:
Indications for Use:
The DOCUMENT® Salicylate CAL•VER® solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification, verification of Analytical Measurement Range (AMR) and verification of the reportable range on immunochemistry and clinical chemistry systems for salicylate. Multiple levels are provided to establish the linear relationship between theorctical operation and actual performance. There exists a linear relationship among each of the solutions.
Ruth Cheda for Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041073
Prescription Use X (Part 21 CFR §801 Subpart D) AND/OR Over-the Counter Use (21 CFR §807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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