(25 days)
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 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.
The provided document is a 510(k) summary for the VALIDATE® Urine Chemistry Calibration Verification Test Sets. This type of device is a quality control material used in laboratories to verify the calibration and linearity of chemistry systems. As such, the concept of "device performance" in this context refers to the characteristics of the calibration verification material itself, rather than a diagnostic algorithm or decision-making aid. Therefore, many of the typical acceptance criteria and study aspects requested (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, effect size) are not applicable or described in the context of this 510(k) summary for a calibration verification material.
Based on the provided text, here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for the performance of the device against a benchmark. Instead, the study's purpose is to demonstrate substantial equivalence to predicate devices. The "performance" being evaluated is the inherent characteristics of the new calibration verification material compared to existing, legally marketed controls.
The comparison table (TABLE 1 on page 1) highlights key characteristics of the new device and predicate devices. The implicit "acceptance criteria" for substantial equivalence would be that the new device shares similar intended use, analytes, matrix, number of levels, preparation, packaging, stability, and storage conditions as the predicates. The summary statement then declares that the new device meets this by claiming "substantial equivalence."
| Characteristic | VALIDATE® Urine Chemistry Calibration Verification Test Sets | Predicate 1: CAP Urine Chemistry Survey | Predicate 2: VALIDATE Chem 1 Calibration Verification Test Set | Predicate 3: Bio-Rad Liquichek™ Urine Chemistry Control |
|---|---|---|---|---|
| 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 |
The document concludes that the VALIDATE® Urine Chemistry Calibration Test Sets are "substantially equivalent" to the predicate devices based on this comparison.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For a calibration verification material, the "test set" would typically refer to the various analytes and levels within the material itself, and the testing would involve evaluating these materials on different analytical systems. The specific details of how many different systems or how many runs were performed are not present. There is no information regarding data provenance (country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the device is a calibration verification material, not a diagnostic algorithm requiring expert interpretation of images or clinical data for ground truth. The "ground truth" for each level of the calibration verification material would be its manufacturing-assigned target value, which is established under strict quality control processes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a calibration verification material.
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. This device is not an AI-powered diagnostic tool used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not a standalone diagnostic algorithm. It is a control material used in a laboratory setting. The "performance" of the device is its ability to provide stable and accurate reference values when tested on analytical systems, allowing those systems to be verified for calibration and linearity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for calibration verification materials typically refers to the assigned values for each analyte at each level. These assigned values are established through rigorous manufacturing processes, often including comparison to reference methods or master lots, and are part of the product specifications. The 510(k) summary does not specify the exact method used by Maine Standards Company to assign these values, but it would be based on internal quality control and analytical chemistry principles.
8. The sample size for the training set
Not applicable. This device is not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
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 TrailWindham, 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 UrineChemistryCallbrationVerification Test Sets | CAP UrineChemistrySurvey | VALIDATE Chem1 CalibrationVerification TestSet | Bio-RadLiquichek™Urine ChemistryControl | |
|---|---|---|---|---|
| Catalog # | 701 / 702 / 703 | LN6-B 2004 | 101 | 398 |
| IntendedUse | For in vitro diagnosticuse in quantitativelyverifying calibration,validating reportableranges, anddetermining linearity inautomated, semi-automated and manualchemistry systems. | For use incalibrationverification /linearity testing ofclinical analyzers | For in vitrodiagnostic use inquantitativelyverifyingcalibration,validatingreportable ranges,and determininglinearity inautomated, semi-automated andmanual chemistrysystems. | For in vitro use asan assayedquality controlurine to monitorthe precision oflaboratory testingprocedures for thelisted analytes. |
| Analytes | 701UA, ETOH, NA, K, CL,GLU, UUN, UTP702CA, MG, PHOS,CREATAMY, p-AMY, MA,703serum osmourine 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 urinehuman serum (osmo) | human urine | aqueous | human urine |
| Number ofLevels | 701 / 7026 including zero7035 levels | 5 | 6 including zero | 1 |
| Preparation | Liquid, ready to use | Liquid, ready touse | Liquid, ready to use | Liquid, ready touse |
| 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 afteropening |
| 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
{2}------------------------------------------------
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).
{3}------------------------------------------------
Page 2 -
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
{4}------------------------------------------------
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
Page 1 of 1
§ 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.