(40 days)
No
The document describes a glucose control solution used for quality control of a blood glucose meter. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the chemical properties of the control solution and its performance in verifying the accuracy of the glucose meter.
No
The device is a control solution used for quality control purposes to verify the performance of a blood glucose meter and test strips, not for direct therapeutic intervention.
No
This device is a control solution used to verify the performance of a blood glucose meter and test strips, not to diagnose a medical condition.
No
The device description clearly states it is an "aqueous control solution," which is a liquid chemical substance, not software. It is used with a blood glucose system, but it is not the system itself, nor is it software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "For use with the AtLast Blood Glucose System for quality control purposes to verify that the AtLast meter and test strips perform well together." This indicates it's used in vitro (outside the body) to assess the performance of a diagnostic system.
- Device Description: It's described as an "aqueous control" intended to be used with a blood glucose system. Control solutions are a standard component of IVD testing to ensure the accuracy and reliability of the test.
- Performance Studies: The document describes performance studies evaluating the precision of the control solutions, which is typical for IVD products.
- Predicate Device: The predicate device listed is another glucose control solution (Accu-Chek® Instant™ Glucose Control), which is also an IVD.
While the AtLast Blood Glucose System itself is the primary diagnostic device, the Glucose Control Solution is an essential component used in vitro to ensure the proper functioning of that diagnostic system. Therefore, it falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For use with the AtLast Blood Glucose System for quality control purposes to verify that the AtLast meter and test strips perform well together.
Product codes
JJX
Device Description
The AtLast Glucose Control Solution is an aqueous control. The control is intended to be used with the Atl.ast Blood Glucose System (AtLast System, K982076) for quality control purposes by the end-user (diabetic consumer). The AtLast System is an over-the-counter (OTC) combination blood sampler and glucose meter that provides blood glucose measurements on samples obtained from various body sites including the forearm, the upper arm, the thigh and the finger tip.
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
diabetic consumer
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
The AtLast Glucose Control solutions were evaluated via comprehensive precision studies. Each level of glucose control was assayed with three AtLast systems, in triplicate, over 20 days. This resulted in a total of 60 measurements per level, per meter. The data were analyzed according to NCCLS Document EP 5-T2. "Evaluation of Precision Performance of Clinical Chemistry Devices," 2™ Edition, Vol. 12, No. 4, and are expressed in terms of: within-run imprecision, and total imprecision.
Key Metrics
within-run imprecision, and total imprecision.
Predicate Device(s)
Reference Device(s)
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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B. 510(k) SUMMARY
Amira Medical 510(k) Premarket Notification for The AtLast™ Control Solution
1. Submitter's Name, Address, Telephone Number, and Contact Person
Amira Medical 4742 Scotts Valley Road Scotts Valley, CA 95066 Phone:(408) 440 5448 Facsimile: (408) 439-0907
Contact Person: Nina Peled, Ph.D., MBA Vice President, Scientific Affairs
2. Date Prepared: March 25, 1999
3. Name of Device and Name/Address of Sponsor
Trade name: The AtLast™ Control Solution
Amira Medical 4742 Scotts Valley Road Scotts Valley, CA 95066
4. Classification Names:
Single (specified) analyte controls (assayed and unassayed) (21 C.F.R. § 862.1660)
5. Predicate Devices
The Accu-Chek® Instant™ (K944459) Glucose Control (Accu-Chek, Roche Diagnostics, Indianapolis, IN.)
6. Intended Use/Indications
For use with the AtLast Blood Glucose System for quality control purposes to verify that the AtLast meter and test strips perform well together.
7. Device Description
The AtLast Glucose Control Solution is an aqueous control. The control is intended to be used with the Atl.ast Blood Glucose System (AtLast System, K982076) for quality control purposes by the end-user (diabetic consumer). The AtLast System is an over-the-counter
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(OTC) combination blood sampler and glucose meter that provides blood glucose measurements on samples obtained from various body sites including the forearm, the upper arm, the thigh and the finger tip.
8. Principle of Operation
The AtLast control solutions are utilized as follows. Users are instructed to tilt the cap of the control packet until it breaks off. A drop of the control solution is then placed on a clean surface. The AtLast test strip is inserted into the AtLast meter in turned on. The tip of the AtLast test strip is then touched to the control solution to draw up the fluid into the AtLast test strip by capillary action and the meter performs the glucose assay. Results are displayed by digital readout of glucose in mg/dL just as would be done with the user's blood sample.
9. Data Demonstrating Substantial Equivalence
The AtLast Glucose Control solutions were evaluated via comprehensive precision studies. Each level of glucose control was assayed with three AtLast systems, in triplicate, over 20 days. This resulted in a total of 60 measurements per level, per meter. The data were analyzed according to NCCLS Document EP 5-T2. "Evaluation of Precision Performance of Clinical Chemistry Devices," 2™ Edition, Vol. 12, No. 4, and are expressed in terms of: within-run imprecision, and total imprecision.
The data indicate qood performance for all qlucose levels.
Conclusion:
The Studies demonstrate that the Amira Medical AtLast Control Solution is safe and effective for its intended use.
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MAR 17 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Nina Peled, Ph.D., MBA Vice President, Scientific Affairs Amira Medical 4742 Scotts Valley Road Scotts Valley California 95066
Re: K991075 Trade Name: The AtLast™ Control Solution Regulatory Class: I Product Code: JJX Dated: March 30, 1999 Received: March 31, 1999
Dear Dr. Peled:
This letter corrects our substantially equivalent letter dated May 10, 1999 to change from prescription use to over-the-couter-use. We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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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 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,
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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8314390970 91704/1995 20:13
AMIRA MEDICAL
Page 1 of 1
Kaarozz (IF KNOWS) : 510 (k) NUMBER
ATLAST GLUCOSE CONTROL SOLUTION DEVICE NAME:
INDICATIONS FOR USE:
an assayed control solution for use with the Atlast Blood Glucose
t and any ality gentrol purposes to verify that the AtLast An assayed control solution for use with the AcLass.
System for quality control purposes to verify that the AtLast
. System for quality concror perform well together.
meter and test strips perform well together.
Peter E. Machi
(Division Sign-Off)
Division of Clinical Laboratory Devices K991015
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTRINUE ON ANOTHER PAGE IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)
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