(29 days)
The PTS PANELS Multi-Chemistry Controls are intended for use to estimate precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation and are intended for use by healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing as well as consumers at home.
The PTS PANELS Multi-Chemistry Controls are intended for use on the BioScanner 2000 and CardioChek brand instruments to estimate precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation and are intended for use by healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing as well as consumers at home.
The PTS PANELS Multi-Chemistry Controls consist of multiple levels of aqueous controls containing cholesterol, triglycerides, ketone (Bhydroxybutyrate) and glucose.
The provided text describes a 510(k) submission for "PTS PANELS Multi-Chemistry Controls" and the FDA's clearance. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The document details:
- Applicant Information: Polymer Technology Systems, Inc.
- Device Description: Aqueous controls containing cholesterol, triglycerides, ketone (B-hydroxybutyrate), and glucose.
- Intended Use: To estimate precision and detect systematic analytical deviations from reagent or instrument variation, for use by healthcare professionals and consumers.
- Predicate Devices: Maine Standards Validate Chem 1 and Chem 3.
- Similarities and Differences between the new device and the predicate devices, primarily regarding the analytes included and the base matrix (aqueous vs. protein-based for one predicate).
- FDA Clearance Letter: Indicating substantial equivalence to marketed predicate devices.
Therefore, I cannot provide the requested table or answer the questions regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.
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AUG 2 1 2002
SECTION E: 510(k) Summary
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- Application Date: July 19, 2002
Summary
- Application Date: July 19, 2002
2. Applicant Information: Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268
Contact Person: Margo Enright 317-870-5610 Phone Number: FAX Number: 317-870-5608 e-mail: mme@diabetes-testing.com
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- Trade Names: PTS PANELS Multi-Chemistry Controls
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- Classification Names: Assayed Quality Control Material
Panel: Clinical Chemistry 75 . Product Code: JJY
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- Facility Address: 7736 Zionsville Road Indianapolis, IN 46268
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- Device Classification: Class I (Regulation: 21 CFR 862.1660)
7. Device Description:
The PTS PANELS Multi-Chemistry Controls consist of multiple levels of aqueous controls containing cholesterol, triglycerides, ketone (Bhydroxybutyrate) and glucose.
8. Intended Use:
The PTS PANELS Multi-Chemistry Controls are intended for use to estimate precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation and are intended for use by healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing as well as consumers at home.
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- Reason for 510(k): New Device
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10. Predicate Device Information
The predicate devices for this submission for determination of substantial equivalence are the Maine Standards Validate Chem 1 and Chem 3.
Information on Predicate Devices
| New Device | Predicate Device | K Number |
|---|---|---|
| PTS PANELS Multi-Chemistry Controls | Maine StandardsValidate Chem 1 | K012117 |
| PTS PANELS Multi-Chemistry Controls | Maine StandardsValidate Chem 3 | K012119 |
Similarities and Differences Between Predicates and New Device
| Items Compared | Similarities | Differences |
|---|---|---|
| PTS PANELS Multi-Chemistry Controls andMaine Standards ValidateChem 1. | Both are aqueous.Both contain glucose andtriglycerides. | The Maine StandardsValidate Chem 1 alsocontains Na, K, Cl, Ca,PO4, BUN, Cre, Mg, Lac,NH3, ETOH and Li.The PTS PANELS Multi-Chemistry Controls alsocontain cholesterol andketone ( B -hydroxybutyrate) |
| PTS PANELS Multi-Chemistry Controls andMaine Standards ValidateChem 3. | Both contain cholesterol. | The Maine StandardsValidate Chem 3 alsocontains total protein,albumin and Fe.The PTS PANELS Multi-Chemistry Controls alsocontains glucose,triglycerides and ketone( B -hydroxybutyrate).The Maine StandardsValidate Chem 3 isprotein based and thePTS PANELS Multi-Chemistry Controls areaqueous. |
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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 eagle or bird symbol, with three human profiles incorporated into its design. The bird is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 1 2002
Ms. Margo Enright Manager of Clinical Affairs Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268
Re: K022401
Trade/Device Name: PTS Panels Multi-Chemistry Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: July 19, 2002 Received: July 23, 2002
Dear Ms. Enright:
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. Iisting 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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/cdrb/dsmaldsmamain.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
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10:5 Food al | Dorg Administration > Center for Devices and Radiological Health
Page / of l
510(k) Number (if known : K022401
Device Name:
Indications for Use:
The PTS PANELS Multi-Chemistry Controls are intended for use on the BioScanner 2000 and CardioChek brand instruments to estimate precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation and are intended for use by healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing as well as consumers at home.
Jan Cooper
(Division Sign-Off)
Ethical Laboratory Devices
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022401
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.