(71 days)
Not Found
No
The summary describes a quality control material for laboratory testing, with no mention of AI or ML technologies.
No
The device is described as quality control material for laboratory test methods, not for direct treatment or diagnosis of patients.
No
This device is described as "quality control material to demonstrate linearity throughout the reportable range of Hemoglobin A1c (HbA1c%)" for test methods, indicating it is used for calibration and quality assurance of other tests, not for directly diagnosing a patient's condition.
No
The device description explicitly states the device is prepared from human blood and provided in liquid form, indicating it is a physical material, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "quality control material to demonstrate linearity throughout the reportable range of Hemoglobin A1c (HbA1c%) for Immunoassay and HPLC test methods". This indicates it's used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: The description mentions it's "prepared from human blood" and used in a "liquid form". This further supports its use as a reagent or control in laboratory testing.
- Predicate Device: The mention of a predicate device (K040535; LiniCAL Enzyme Calibration Verifiers) which is also a quality control material for diagnostic tests, strongly suggests this device falls under the same regulatory category, which is IVD.
Therefore, the primary function of this device is to be used in vitro to evaluate the accuracy and performance of other diagnostic tests, which is the definition of an IVD.
N/A
Intended Use / Indications for Use
Hemoglobin Alc Linearity is intended for use as quality control material to demonstrate linearity throughout the reportable range of Hemoglobin A1c (HbA1c%) for Immunoassay and HPLC test methods using protocols established in individual laboratories.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The HbAIc Linearity Set is prepared from human blood to which stabilizers are added. The control is provided in liquid form for user convenience.
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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OCT 4 - 2005
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: K052010
Submitter:
Cone Bioproducts 1008 N. River Street Seguin, TX 78155
Telephone: (830)379-0197 Facsimile: (830)379-0471
Contact Person:
William K. Cone Regulatory Affairs Officer Telephone: (830)379-0197 ext. 203 Facsimile: (839)379-0471
Preparation Date:
September 1, 2005
Device Information:
Proprietary Name: Regulation Number: Regulatory Name: Product Code: Regulatory Class:
HbA1c Linearity Set 21 CFR8862.1660 Quality Control Material (assayed and unassayed) JJX Class I
Predicate Devices:
The HbA1c Linearity Set is substantially equivalent to LiniCAL Enzyme Calibration Verifiers (K040535) for its stated intended use.
Device Description:
The HbAIc Linearity Set is prepared from human blood to which stabilizers are added. The control is provided in liquid form for user convenience.
Intended Use:
Hemoglobin Alc Linearity is intended for use as quality control material to demonstrate linearity throughout the reportable range of Hemoglobin A1c (HbA1c%) for Immunoassay and HPLC test methods using protocols established in individual laboratories.
1
Comparison to Predicate Device(s):
Cone Bioproducts' HbA1c Linearity Set is substantially equivalent to LiniCAL Enzyme Calibration Verifiers (K040535) for its stated intended use.
| Device
Characteristics | Subject Device
Hemoglobin A1c Linearity Set | Predicate Device(s)
LiniCAL Enzyme Calibration
Verifiers (K040535) |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Hemoglobin A1c Linearity is intended
for use as quality control material to
demonstrate the linearity of
Hemoglobin A1c (HbA1c%) for
Immunoassay and HPLC test methods
using protocols established in
individual laboratories. | LiniCAL Enzyme Calibration
Verifiers are intended for use in the
clinical laboratory to verify
calibration and/or linearity of the
Beckman Coulter Synchron Protein
Systems. Five assayed levels of
Alkaline Phosphatase, Alanine
Aminotransferase, Amylase, Asparate
Aminotransferase, Cholinesterase,
Creatine Kinase, Creatine Kinase MB,
Lactate Dehydrogenase, Lipase,
Gamma Glutamyl Transferase, and
Pancreatic Amylase are provided to
allow monitoring of the reportable
range. |
| Analyte | Single Constituent :
A1c | Multiple Constituents:
Alkaline Phosphatase, Alanine
Aminotransferase, Amylase, Asparate
Aminotransferase, Cholinesterase,
Creatine Kinase, Creatine Kinase MB,
Lactate Dehydrogenase, Lipase,
Gamma Glutamyl Transferase, and
Pancreatic Amylase |
| Methodology/
Analyzers | Compatible with Immunoassay and
HPLC HbA1c test methods. | Beckman Coutler Sychron |
| Matrix | Human Blood | Human and Bovine Serum |
| Control Form | Liquid | Liquid |
| Levels | 1-4 (4) | A-E (5) |
| Storage | -20°C | 2°C to 8°C |
| Stability | Unopened vial stability (-20°C):
2 Years
Opened vial stability (2-8°C):
14 days | Unopened vial stability (2-8°C):
3 Years
Opened vial stability (2-8°C):
14 days |
Summary:
The information provided in this pre-market notification demonstrates that Cone Bioproducts' A l c Linearity Set is substantially equivalent to LiniCAL Enzyme Calibration Verifiers (K040535). Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate device. The information supplied in this pre-market notification provides reasonable assurance that the Cone Bioproducts' A1c Linearity Set is safe and effective for its stated intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 4 - 2005
Mr. William Cone Regulatory Affairs Officer Cone Bioproducts 1008 N. River Street Seguin, TX 78155
Re: K052010
Trade/Device Name: Cone Bioproducts HbA1c Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: September 1, 2005 Received: September 16, 2005
Dear Mr. Cone:
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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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.
Carol C. Benson
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
SECTION III
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Indications for Use
510(k) Number (if known): ________k052010
Device Name: Cone Bioproducts' HbA Ic Linearity Set
Indications For Use:
Hemoglobin Alc Linearity is intended for use as quality control material to demonstrate linearity throughout the richtogloum ATC 2nioans 13 interest to 125 as quarty and HPLC test methods using protocols established in individual laboratories.
Prescription Use (Part 21 CFR 801 Subpart D)
0
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) Division Sign-Off Office of in Vitro Dingnostic Device Evaluation and Sarely