(55 days)
Not Found
No
The device description and performance studies focus on the stability and precision of a control material for HbA1c testing, with no mention of AI or ML technologies.
No
The device is described as an "assayed control for monitoring performance of analysis procedures for HbA1c", which indicates it is used for quality control in testing, not for treating a patient.
No
A1c-Chex is described as an "assayed control" used for "monitoring performance of analysis procedures for HbA1c", not for diagnosing a patient's condition. It serves as a quality control material rather than a diagnostic tool.
No
The device description clearly states it is a "whole blood based, assayed control," indicating it is a physical substance used for quality control, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that A1c-Chex is for "monitoring performance of analysis procedures for HbA1c." This indicates it's used in vitro (outside the body) to assess the accuracy and reliability of a diagnostic test (HbA1c analysis).
- Device Description: The description further clarifies that it's a "whole blood based, assayed control" and is "tested following the instructions included with the instrument, kit or reagent being used." This confirms its role as a control material used in the laboratory setting to evaluate the performance of other diagnostic devices or procedures.
- Nature of HbA1c: HbA1c is a measure of average blood glucose levels over the past 2-3 months, and its analysis is a common in vitro diagnostic test for diabetes management.
- Predicate Device: The mention of a predicate device (K023307; MAS® Medical Analysis Diabetes Control) which is also a control material for diabetes testing further supports its classification as an IVD.
In summary, A1c-Chex is a control material used to verify the performance of an in vitro diagnostic test (HbA1c analysis), which is a key characteristic of an IVD.
N/A
Intended Use / Indications for Use
A1c-Chex is a bi-level whole blood based, assayed control for monitoring performance of analysis procedures for HbA1c.
Product codes
JJX
Device Description
A1c-Chex is bi-level, whole blood based, assayed control for monitoring performance of tastal A IC-Chex is blevel, whole blood, acouryed of he same as a patient specimen and tested procedures for ribATC. ATT offex brith the instrument, kit or reagent being used. A1c-Chex following the instructions included with the including in oversion of analysis procedures, including lysing of the RBC.
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)
Studies were conducted to establish performance of A1c-Chex:
- a.) Stability closed and open vial stability
- b.) Percision Test
- c.) Proposed Assay Sheet
Study results show A1c-Chex to be consistently reproducible, substantially equivals to the offective Study Testills show A16-Ohex to be entire product dating. A1c-Chex is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/0 description: The image shows the date "MAR - 2 2004". The month is "MAR", the day is "2", and the year is "2004". The text is black and the background is white.
510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck Laboratories
7002 South 109th Street
La Vista, NE 68128 |
|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Official Correspondent: | Carol Thompson, Quality Assurance Manager
(402) 537-5313 |
| Date Prepared: | January 7, 2004 |
| Names of Device:
Trade Name:
Common Name:
Classification Name: | A1c-Chex
Clinical Chemistry Test Systems
Quality Control Material, 21CFR862.1660 |
| Predicate Device: | MAS® Medical Analysis Diabetes Control – 510(k) #K023307 |
Description:
A1c-Chex is bi-level, whole blood based, assayed control for monitoring performance of tastal A IC-Chex is blevel, whole blood, acouryed of he same as a patient specimen and tested procedures for ribATC. ATT offex brith the instrument, kit or reagent being used. A1c-Chex following the instructions included with the including in oversion of analysis procedures, including lysing of the RBC.
Intended Use:
Monitoring the concentration of glycated hemoglobin is an important part of diabetes management. Momioning the concentration of gryssted in by several methods, which are based on mmmodest and Hemogram ATC IS the analyte medding by overal moets as a whole blood material that closely lori exchange and boronato animaly the complete analytical process.
Comparison with Predicate Device:
rison with Preuileate Device:
A1c-Chex and MAS® Diabetes Control are similar and have the same intended application,
A1c-Chex is a whole blood control. It should be treated the same as a patient specimen and A1c-Chex is a whole blood control. It should be teated the spealent being used. MAS®
tested following the instructions included with the instrument, Kiss of Chiles in tested following the instructions included prepared from human whole blood adjusted to specific concentrations of glycated hemoglobin.
A1c-Chex has an open vial stability of 30 days and MAS® Diabetes Control has an open vial stability of 14 days.
Testing Performed:
Studies were conducted to establish performance of A1c-Chex:
- a.) Stability closed and open vial stability
- b.) Percision Test
- c.) Proposed Assay Sheet
Conclusions Drawn from the Tests:
Study results show A1c-Chex to be consistently reproducible, substantially equivals to the offective Study Testills show A16-Ohex to be entire product dating. A1c-Chex is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the symbol in a circular fashion.
MAR - 2 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kerrie Oetter Quality Assurance/Regulatory Affairs Streck Laboratories®, Inc. 7002 South 109th Street LaVista, NE 68128
K040025 Re:
Trade/Device Name: A1c-Chex Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: January 7, 2004 Received: January 7, 2004
Dear Ms. Oetter:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your bected. o reley person is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosal of to 10gains acted of the Medical Device Amendments, or to conninered print to may 20, 1978, in ecordance with the provisions of the Federal Food, Drug, devices mat nave been rechasined in avire approval of a premarket approval application (PMA). alle Cosmetic recry treef market the device, subject to the general controls provisions of the Act. The 1 but may, mercere, manxer alle act include requirements for annual registration, listing of general controls provision 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 If your device is classified (too as ontrols. Existing major regulations affecting your device can may be subject to Such adultions (CFR), Parts 800 to 895. In addition, FDA be found in This 21, oncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that i be resum that your device complies with other requirements of the Act that I Dr has Intact a determinations administered by other Federal agencies. You must or any I cachar stutures and registments, including, but not limited to: registration and listing (21 Comply with and the 11et 67equire.Parts 801 and 809); and good manufacturing practice CFR Part 801), labeling systems (QS) regulation (21 CFR Part 820).
2
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in your he FDA finding of substantial equivalence of your device to a legally premarket notineated. "The stars 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 or questions on the Presise Evaluation and Safety at (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
Yean 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
3
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
A1c-Chex is a bi-level whole blood based, assayed control for monitoring performance of analysis procedures for HbA1c.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
ાર
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Carol C Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and
510(k) K040025