(32 days)
Not Found
No
The device is a calibration verification test set for in vitro diagnostic use, and the description focuses on its chemical composition and intended use in chemistry systems, with no mention of AI or ML.
No
The device is an in vitro diagnostic (IVD) product used for calibrating and verifying the performance of chemistry systems, not for treating or diagnosing diseases in patients.
No
This device is a calibration verification test set, used to establish the relationship between theoretical operation and actual performance of chemistry systems measuring certain analytes. It is not used to diagnose a patient's condition directly, but rather to ensure the accuracy of other diagnostic devices.
No
The device description clearly states it is a "human serum calibration verification / linearity materials containing multiple levels," indicating it is a physical reagent product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the solutions are "intended for in vitro diagnostic use".
- Device Description: The device is described as "human serum calibration verification / linearity materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes." This aligns with the purpose of IVD devices, which are used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Intended User / Care Setting: It is intended for use in "automated, semi-automated and manual chemistry systems," which are common settings for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The VALIDATE® SP1 Calibration Verification Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated ond manual chemistry systems for the following analytes: Immunoglobulin A (lgA), Immunoglobulin G (lgG), 11 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = ( = 1 = ( = ) = ( = ) = ( = ) = ( = ) = ( = ) = ( = ) = ( = ) = ( = ) = ( = ) = ( = ) in (And Transferrin (TRF). VALIDATE® SP1 Calibration Verification Verification Test Set solutions are not intended for use as routine quality control materials or as calibration materials.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
VALIDATE® SP1 Calibration Verification Test Sets are human serum calibration verification / linearity materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each test set consists of one bottle each of five (5) levels. Each bottle of Levels 1 through 5 contains 1.0 milliliter. There exists a linear relationship between Levels 1 through 5.
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)
The information provided in this pre-market notification demonstrates that the performance of VALIDATE® SP1 Calibration Verification Test Sets is substantially equivalent in form and function to the predicate devices 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.
0
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 07224
| Submitter: | Maine Standards Company |
|---|---|
| Address: | 765 Roosevelt Trail |
| Windham, ME 04062 | |
| Telephone: | 207-892-1300 |
| Fax: | 207-892-2266 |
| Contact: | Holly A. Cressman, Mgr. QA/RA |
Summary prepared on: August 01, 2007
Device classification name: Multi-Analyte Controls, All Kinds (Assayed and Unassayed) Device description: Quality control material (assayed and unassayed) VALIDATE® SP1 Calibration Verification Test Set Proprietary Name: Regulation Number: 21 CFR 862.1660 Product Code: JJY Regulatory Class: Class I
Predicate Device:
Cliniqa LiniCAL® Calibration Verifier Protein 1 (K031575) and Cliniqa LiniCAL® Calibration Verifier Protein 2 (K031577) Cliniqa, San Marcos, California.
Device description: VALIDATE® SP1 Calibration Verification Test Sets are human serum calibration verification / linearity materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each test set consists of one bottle each of five (5) levels. Each bottle of Levels 1 through 5 contains 1.0 milliliter. There exists a linear relationship between Levels 1 through 5.
Intended use: The VALIDATE® SP1 Calibration Verification Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated ond manual chemistry systems for the following analytes: Immunoglobulin A (lgA), Immunoglobulin G (lgG), 11 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = ( = 1 = ( = ) = ( = ) = ( = ) = ( = ) = ( = ) = ( = ) = ( = ) = ( = ) = ( = ) = ( = ) in (And Transferrin (TRF). VALIDATE® SP1 Calibration Verification Verification Test Set solutions are not intended for use as routine quality control materials or as calibration materials.
Summary:
The information provided in this pre-market notification demonstrates that the performance of VALIDATE® SP1 Calibration Verification Test Sets is substantially equivalent in form and function to the predicate devices for its stated intended use.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the bird-like figure.
SEP 1 4 2007
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Maine Standards Co. c/o Ms. Holly Cressman Manager, QA/RA 765 Roosevelt Trail Windham, ME 04062-5365
Re: K072246
Trade/Device Name: VALIDATE® SP1 Calibration Verification Test Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: August 08, 2007 Received: August 13, 2007
Dear Ms. Cressman:
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 (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The
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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) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
Robert W. Becker
Robert L. Becker, Jr., M.D., Ph/D. Director Division of Immunology and Hematology Devices 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:
VALIDATE® SP1 Calibration Verification Test Set Device Name:
Indications For Use:
VALIDATE® SP1 Calibration Verification Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range in automated, semi-automated and manual chemistry systems for the following analytes: Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Complement C3 (C3), Complement C4 (C4), c1-Antitrypsin (AAT), and Transferrin (TRF).
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 In Vitro Diagnostic Devices (OIVD)
Maria M. Chan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Ko72246
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