(27 days)
Not Found
No
The summary describes a quality control material for laboratory testing and does not mention any AI or ML components.
No
The device is a quality control material used to monitor the performance of Hemoglobin A1c determination methods, not to treat or diagnose a condition.
No
Explanation: This device is explicitly described as quality control material to monitor the performance and precision of Hemoglobin A1c determination methods, not for direct diagnosis of a patient's condition.
No
The device description clearly states the device is a liquid control material prepared from human blood with added chemicals, preservatives, and stabilizers. This is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for "quality control material to monitor the performance and precision of Hemoglobin A1c determination methods." This indicates it is used in vitro (outside the body) to assess the accuracy and reliability of diagnostic tests.
- Device Description: The description mentions it is "prepared from human blood" and is a "control" material. Control materials are a key component of IVD testing to ensure the test is working correctly.
- Performance Studies: The document details performance studies related to "Value Assignment," "CLOSED VIAL STABILITY," and "OPEN VIAL STABILITY." These are all standard types of studies performed on IVD devices to demonstrate their performance characteristics.
- Predicate Device: The mention of a "Predicate Device" with a K number (K052010) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
Therefore, based on the provided information, the CONE-TROL Hemoglobin A1c Control Set clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CONE-TROL Hemoglobin A1c Control Set is intended for use as quality control material to monitor the performance and precision of Hemoglobin A 1 c determination methods.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The CONE-TROL Hemoglobin A 1c Control Set is prepared from human blood to which chemicals, preservatives, and 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
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Intended User / Care Setting
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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)
CLOSED VIAL STABILITY
The shelf life for CONE-TROL HbA ic Control Set has been determined based upon accelerated stability studies to be confirmed by real time stability studies. The expiration for CONE-TROL HbA1c Control Set is 2 years at -20°C and for 180 days at 2-8°C from the date of manufacture.
The product stability has been extrapolated from accelerated studies with elevated temperatures and will be confirmed by real time studies. Hemoglobin A 1c concentrations were analyzed using the Tosoh G7 HPLC Analyzer. Vials were stored at -20°C and 37°C and values were obtained between 0 and 30 hours.
The O Rule Table based on the Arrhenius Equation was used to estimate the shelf life during the accelerated stability study. The Q Rule states that a product's degradation rate decreases by a constant factor (Q=4) every 10°C decrease in temperature. For the test point to be valid the analyte activity must fall ± 10% from the initial value.
Table VII-1: Accelerated Closed Vial Stability of CONE-TROL Hemoglobin A1c Control Set at 37°C
Analyte: HbA1c-Level 1; Initial Value: 5.3%; Concentration at 30 hours: 5.4%; Percent Change: 1.89%; Concentration Range Accepted by Company: 4.2-6.4%
Analyte: HbA1c-Level 2; Initial Value: 10.8%; Concentration at 30 hours: 10.8%; Percent Change: 0%; Concentration Range Accepted by Company: 8.6-13.0%
To date, real time stability studies confirm the accelerated stability studies through 210 days. Closed Vial real time stability will be monitored throughout the life of the product. Closed Vial stability data will be collected at six month intervals. For the test point to be valid the analyte activity must fall ± 10% from the initial value.
Table VII-2: Real Time Closed Vial Stability at -20°C
Analyte: HbA1c-Level 1; Initial Value: 5.3%; Concentration at 210 days: 5.4%; Percent Change: 1.89%; Concentration Range Accepted by Company: 4.2-6.4%
Analyte: HbA1c-Level 2; Initial Value: 11.9%; Concentration at 210 days: 12.1%; Percent Change: 1.68%; Concentration Range Accepted by Company: 9.5-14.3%
Based on the data given in Table VII-1, CONE-TROL Hemoglobin A1c Control Set will be stable for 2 years when stored at -20°C as specified in the product insert.
OPEN VIAL STABILITY
The open vial, 2-8°C stability of CONE-TROL Hemoglobin A 1c Control Set has been determined from real time stability testing. HbA1c concentrations were determined using a Tosoh G7 HPLC Analyzer. CONE-TROL Hemoglobin A1c Control Set was stored as described in the package insert. Values for Hemoglobin A1c were collected through 210 days.
Table VII-3: Open Vial Stability of CONE-TROL Hemoglobin A1c Control Set at 2-8°C
Analyte: HbA1c-Level 1; Initial Value: 5.3%; Concentration at 210 days: 5.0%; Percent Change: 5.7%; Concentration Range Accepted by Company: 4.2-6.4%
Analyte: HbA1c-Level 2; Initial Value: 11.9%; Concentration at 210 days: 11.5%; Percent Change: 3.4%; Concentration Range Accepted by Company: 9.5-14.3%
Based on the data presented in Table VII-3, at the present time, CONE-TROL Hemoglobin A 1c Control Set will be given an expiration date of 180 days when stored at 2-8°C as described in the package insert.
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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JUN 2 0 2012
SECTION V
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: k
Submitter:
Cone Bioproducts 1012 N. Austin St. Seguin, TX 78155
Telephone: (830)379-0197 Facsimile: (830)379-0471
Contact Person:
Gail Schievelbein . Project Manager Telephone: (830)379-197 ext. 206 Facsimile: (839)379-0471
Preparation Date:
June 13, 2012
Device Information:
Device Classification Name: Single Analyte Controls
Proprietary Name: Regulation Number: Product Code: Regulatory Class:
(Assayed and Unassyed) CONE-TROL Hemoglobin A lc Control Set 21 CFR8862.1660 אוו Class I
Predicate Devices:
The CONE-TROL Hemoglobin Alc Control Set is substantially equivalent to Cone Bioproducts' HbA1c Linearity Set (K052010) for its stated intended use.
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Device Description:
The CONE-TROL Hemoglobin A 1c Control Set is prepared from human blood to which chemicals, preservatives, and stabilizers are added. The control is provided in liquid form for user convenience.
Intended Use:
CONE-TROL Hemoglobin A1c Control Set is intended for use as quality control material to monitor the performance and precision of Hemoglobin A 1c determination methods.
Comparison to Predicate Device(s):
CONE-TROL Hemoglobin A 1c Control Set is substantially equivalent to Cone Bioproducts' HbA lc Linearity Set, (K052010) for its stated intended use.
| Device
Characteristics | Subject Device | Predicate Device(s)
K052010 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | CONE-TROL Hemoglobin A1c
Control Set is intended for use as
quality control material to monitor the
performance and precision of
Hemoglobin A1c determination
methods. | HbA1c Linearity Set is intended for
use as quality control material to
monitor the linearity throughout the
reportable range of Hemoglobin A1c
assays using protocols established in
individual laboratories. |
| Analyte | A1c | A1c |
| Methodology | Compatible with Immunoassay and
HPLC HbA1c test methods. | Compatible with Immunoassay and
HPLC HbA1c test methods. |
| Matrix | Human Blood, stabilizers, and
preservative. | Human Blood, stabilizers, and
preservative. |
| Control Form | Liquid | Liquid |
| Levels | 1-2 | 1-4 |
| Storage | -20°C | -20°C |
| Stability | Unopened vial stability (-20°C):
2 Years
Unopened vial stability (2-8°C):
180 days
Opened vial stability (2-8°C):
180 days | Unopened vial stability (-20°C):
2 Years
Opened vial stability (2-8°C):
14 days |
2
Summary:
Value Assignment:
Levels 1 and 2 are prepared so that Level 1 meets the clinically normal range of HbAIc, and Level 2 meets the clinically abnormal range of HbA lc on the manufacturer's instrument. Levels 1 and 2 are assayed in triplicate on the applicable instrument system. When the recovery falls within ±10% of the target concentration, the CONE-TROL Hemoglobin Alc Control Set is labeled and filled. QC testing for value assignment is performed for Levels 1 and 2 of control. Two vials are assayed in triplicate over a minimum of 2 days and maximum of 7 day period on the Immunoassay or HPLC test method for which the product is designed. A minimum of 6 data points for each level is required for value assignment. One instrument may be used if used on two different days or by two different operators. The mean, standard deviation and coefficient of variance is determined for each instrument for each level of control.
CLOSED VIAL STABILITY
The shelf life for CONE-TROL HbA ic Control Set has been determined based upon accelerated stability studies to be confirmed by real time stability studies. The expiration for CONE-TROL HbA1c Control Set is 2 years at -20°C and for 180 days at 2-8°C from the date of manufacture.
The product stability has been extrapolated from accelerated studies with elevated temperatures and will be confirmed by real time studies. Hemoglobin A 1c concentrations were analyzed using the Tosoh G7 HPLC Analyzer. Vials were stored at -20°C and 37°C and values were obtained between 0 and 30 hours.
The O Rule Table based on the Arrhenius Equation was used to estimate the shelf life during the accelerated stability study. The Q Rule states that a product's degradation rate decreases by a constant factor (Q=4) every 10°C decrease in temperature. For the test point to be valid the analyte activity must fall ± 10% from the initial value.
| Table VII-1: Accelerated Closed Vial Stability of CONE-TROL Hemoglobin A1c | |
|---|---|
| Control Set at 37°C |
| Analyte | Initial Value | Concentration at
30 hours | Percent
Change | Concentration
Range Accepted
by Company |
|---------------|---------------|------------------------------|-------------------|-----------------------------------------------|
| HbA1c-Level 1 | 5.3% | 5.4% | 1.89% | 4.2-6.4% |
| HbA1c-Level 2 | 10.8% | 10.8% | 0% | 8.6-13.0% |
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3
To date, real time stability studies confirm the accelerated stability studies through 210 days. Closed Vial real time stability will be monitored throughout the life of the product. Closed Vial stability data will be collected at six month intervals. For the test point to be valid the analyte activity must fall ± 10% from the initial value.
| Analyte | Initial Value | Concentration at
210 days | Percent
Change | Concentration
Range Accepted
by Company |
|---------------|---------------|------------------------------|-------------------|-----------------------------------------------|
| HbA1c-Level 1 | 5.3% | 5.4% | 1.89% | 4.2-6.4% |
| HbA1c-Level 2 | 11.9% | 12.1% | 1.68% | 9.5-14.3% |
Table VII-2: Real Time Closed Vial Stability at -20°C
Based on the data given in Table VII-1, CONE-TROL Hemoglobin A1c Control Set will be stable for 2 years when stored at -20°C as specified in the product insert.
OPEN VIAL STABILITY
The open vial, 2-8°C stability of CONE-TROL Hemoglobin A 1c Control Set has been determined from real time stability testing. HbA1c concentrations were determined using a Tosoh G7 HPLC Analyzer. CONE-TROL Hemoglobin A1c Control Set was stored as described in the package insert. Values for Hemoglobin A1c were collected through 210 days.
Table VII-3: Open Vial Stability of CONE-TROL Hemoglobin A1c Control Set at 2-8°C
| Analyte | Initial Value | Concentration at
210 days | Percent
Change | Concentration
Range Accepted
by Company |
|---------------|---------------|------------------------------|-------------------|-----------------------------------------------|
| HbA1c-Level 1 | 5.3% | 5.0% | 5.7% | 4.2-6.4% |
| HbA1c-Level 2 | 11.9% | 11.5% | 3.4% | 9.5-14.3% |
Based on the data presented in Table VII-3, at the present time, CONE-TROL Hemoglobin A 1c Control Set will be given an expiration date of 180 days when stored at 2-8°C as described in the package insert.
Substantial Equivalence:
The information provided in this pre-market notification demonstrates CONE-TROL Hemoglobin A 1 c Control Set is substantially equivalent to Hemoglobin A 1 c Linearity Set (K052010). 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-TROL Hemoglobin A 1c Control Set is safe and effective for its stated intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/2 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the left side of the seal. To the right of the text is a symbol that resembles an eagle or a bird in flight, with three stylized human profiles incorporated into the design. The overall impression is that of an official emblem or logo, likely representing a government agency related to health and human services in the United States.
10903 New Hampshire Avenue Silver Spring, MD 20993
Cone Bioproducts Ms. Gail Schievelbein Project Manager 1012 N. Austin St. Seguin, TX 78155
JUN 2 0 2012
Re: K121534
Trade/Device Name: CONE-TROL Hemoglobin Alc Control Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: Class I, reserved Product Code: JJX Dated: May 2, 2012 Received: May 24, 2012
Dear Ms. Schievelbein:
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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours.
N
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE STATEMENT
+121.534 510(k) Number (if known):
CONE-TROL Hemoglobin A1c Control Set Device name:
Indications for Use:
CONE-TROL Hemoglobin A1c Control Set is intended for use as quality control material to monitor the performance and precision of Hemoglobin A 1 c determination methods.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Russell Chun
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K121534 510(k)
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