(25 days)
No
The document describes a calibration verification test set for laboratory chemistry systems and does not mention any AI or ML components.
No.
The device is used for verifying calibration and determining linearity in chemistry systems, not for treating or diagnosing medical conditions in patients.
No
This device is described as a calibration verification material used to assess the performance of chemistry systems, not to diagnose a patient's condition. It ensures the accuracy of laboratory equipment, which then may be used for diagnostic purposes.
No
The device description explicitly states that the device is "human urine or serum based calibration verification materials," indicating it is a physical substance, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the test sets are used by trained laboratory professionals for "quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the analytes listed on the package insert." This describes a process performed in vitro (outside the body) on samples (urine or serum) to assess the performance of diagnostic instruments.
- Device Description: The description states the test sets are "human urine or serum based calibration verification materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes." This further confirms that the device is a reagent or material used in a laboratory setting for diagnostic purposes (specifically, ensuring the accuracy of diagnostic tests).
- Intended User / Care Setting: The intended user is "trained laboratory professionals," which is typical for IVD devices used in clinical laboratories.
The purpose of these test sets is to ensure the accuracy and reliability of other diagnostic tests performed on urine or serum samples. This function falls squarely within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VALIDATE® Urine Chemistry Calibration Verification Test Sets are used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the analytes listed on the package insert.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
VALIDATE Urine Chemistry Calibration Verification Test Sets are human urine or serum based calibration verification materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. There exists a linear relationship among each set of splutions.
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
trained laboratory professionals
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The information provided in this pre-market notification demonstrates that the performance of VALIDATE Urine Chemistry Calibration Test Sets is substantially equivalient I NO D COS . VALD Chemistry Survey (Calibration Verification Verification / Lineanity) LN6-B 2004, VALIDATE Chem 1 Calibration Verification Test Set (K012120), and Bio-Rad Liquichek Urine Chemistry Control (K934357) for its stated intended use
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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Image /page/0/Picture/0 description: The image shows a logo for "maine/standards COMPANY LLC". The word "maine" is on the top line, with a line going through it. The word "standards" is on the second line, and the words "COMPANY LLC" are on the third line. There is also a stamp in the upper right corner that says "MAR 25 2005".
510(k) SUMMARY
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: K o 505
| Submitter: | Maine Standards Company |
|---|---|
| Address: | 765 Roosevelt Trail |
| Windham, ME 04062 | |
| Telephone: | 207-892-1300 |
| Fax: | 207-892-2266 |
| Contact: | Christine Beach, Dir. RA/QA |
Summary prepared on: February 18, 2005
| Device classification name: | Multi-Analyte Controls, All Kinds (Assayed and Unassayed) |
|---|---|
| Device description: | Quality control material (assayed and unassayed) |
| Proprietary Name: | VALIDATE® Urine Chemistry Calibration Verification Test Sets |
| Regulation Number: | 21 CFR 862.1660 |
| Product Code: | JJY |
| Regulatory Class: | Class I |
Predicate Device:
-
- Chem 1 Calibration Verification Test Set (K012117), manufactured by Maine Standards Company, Windham, ME.
-
- Bio-Rad Liquichek Urine Chemistry Control (K934357), Bio-Rad Laboratories, Irvine, CA
-
- College of American Pathologists (CAP) Urine Chemistry Survey (Calibration Verification / Linearity) LN6-B 2004, Northfield, IL
Device description: VALIDATE Urine Chemistry Calibration Verification Test Sets are human urine or serum based calibration verification materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. There exists a linear relationship among each set of splutions.
1
Intended use: The VALIDATE Urine Chemistry Calibration Verification Test Sets are used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the analytes listed on the package insert.
| | VALIDATE Urine
Chemistry
Callbration
Verification Test Sets | CAP Urine
Chemistry
Survey | VALIDATE Chem
1 Calibration
Verification Test
Set | Bio-Rad
Liquichek™
Urine Chemistry
Control |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 701 / 702 / 703 | LN6-B 2004 | 101 | 398 |
| Intended
Use | For in vitro diagnostic
use in quantitatively
verifying calibration,
validating reportable
ranges, and
determining linearity in
automated, semi-
automated and manual
chemistry systems. | For use in
calibration
verification /
linearity testing of
clinical analyzers | For in vitro
diagnostic use in
quantitatively
verifying
calibration,
validating
reportable ranges,
and determining
linearity in
automated, semi-
automated and
manual chemistry
systems. | For in vitro use as
an assayed
quality control
urine to monitor
the precision of
laboratory testing
procedures for the
listed analytes. |
| Analytes | 701
UA, ETOH, NA, K, CL,
GLU, UUN, UTP
702
CA, MG, PHOS,
CREAT
AMY, p-AMY, MA,
703
serum osmo
urine osmo | AMY, CA, CREAT,
GLU, OSMO,
UTP, PHOS, K,
NA,
UUN, UA | NA, K, CL, CA,
PHOS GLU, BUN,
CRE, TRIG, MG,
LAC, LI | AMY, CA, CL,
CORTISOL,
CREAT, GLU,
MG, MA, OSMO,
PHOS, K, UTP,
NA, BUN, UUN,
UA |
| Matrix | human urine
human serum (osmo) | human urine | aqueous | human urine |
| Number of
Levels | 701 / 702
6 including zero
703
5 levels | 5 | 6 including zero | 1 |
| Preparation | Liquid, ready to use | Liquid, ready to
use | Liquid, ready to use | Liquid, ready to
use |
| Packaging | 3.0 mL each level | 5.0 mL each level | 5.0 mL each level | 10 mL |
| Stability | Until Expiration | 14 days | Until Expiration | 30 days after
opening |
| Storage | 2 to 8°C | 2 to 8°C | 2 to 8°C | 2 to 8°C |
TABLE 1: Comparison of VALIDATE Urine Chemistry Calibration Verification Test Sets to the predicate devices:
Summary:
The information provided in this pre-market notification demonstrates that the performance of VALIDATE Urine Chemistry Calibration Test Sets is substantially equivalient I NO D COS . VALD Chemistry Survey (Calibration Verification Verification / Lineanity) LN6-B 2004, VALIDATE Chem 1 Calibration Verification Test Set (K012120), and Bio-Rad Liquichek Urine Chemistry Control (K934357) for its stated intended use
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three curved lines that resemble a person's head and torso. The figure is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 5 2005
Ms. Christine Beach Director, QA/RA Maine Standards Company 765 Roosevelt Trail Windham. ME 04062
Re: K050504
Trade/Device Name: VALIDATE® Urine Chemistry Calibration Verification Test Sets Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: February 25, 2005 Received: March 2, 2005
Dear Ms. Beach:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 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 marketed 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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. 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/industry/support/index.html
Sincerely yours,
Sean M. Cooper, MS, DUM
Jean 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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Indications for Use
510(k) Number (if known): _ K050504
Device Name: VALIDATE® Urine Chemistry Calibration Verification Test Sets
Indications For Use:
The VALIDATE® Urine Chemistry Calibration Verification Test Sets are used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the analytes listed on the package insert.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol Benson
Dixie Off
Diagnostic
and Safety
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