(29 days)
Maine Standards Company VALIDATE CHEM 3 Calibration Verification Test Set
Roche Integra 700/800
No
The device description and intended use indicate a simple serum-based assay verification set, with no mention of AI/ML terms or functionalities.
No
Explanation: The device is an "Assay Verification Set" intended for "In Vitro Diagnostic Use" to verify the accuracy of a test (ACB Test) on an analytical instrument (Roche Integra 700/800). It is used for quality control of an in-vitro diagnostic assay, not for treating a disease or condition in a patient.
No
The Ischemia ACB® Assay Verification Set is intended for verifying the accuracy of the ACB Test, not for directly diagnosing a condition in a patient. It is a control or calibration material for a diagnostic test.
No
The device description explicitly states it consists of "twenty (20) single vial 0.5 mL aliquots of frozen serum based samples," which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use."
This statement is the primary indicator that the device is intended for use in the in vitro examination of specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Ischemia ACB® Assay Verification Set is intended for use in verifying accuracy of the ACB Test on the Roche Integra 700/800. It is recommended as a part of assay installation. For In Vitro Diagnostic Use.
Product codes
JJX
Device Description
The Assay Verification Set consists of twenty (20) single vial 0.5 mL aliquots of frozen serum based samples with assigned IMA values over the physiological range.
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
The Assay Verification Set was evaluated for expiry date and for range setting values internally and at multiple clinical sites.
Key Metrics
Not Found
Predicate Device(s)
Maine Standards Company VALIDATE CHEM 3 Calibration Verification Test Set
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.
0
K 060/33
510(k) Summary
| Submitted by: | James M. Delaney
Inverness Medical Innovations, Inc.
51 Sawyer Rd., Ste. 200
Waltham, MA 02453 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared on: | January 12, 2006 |
| Device name | The Ischemia Albumin Cobalt Binding Test (ACB® Test) Assay Verification
Set |
| Classification
name | Quality Control Material (assayed and unassayed) |
| | The Assay Verification Set is classified as Class I, Clinical Chemistry Panel
(75), Pro Code JJX-Single (Specified) Analyte Controls (Assayed and
Unassayed). The device is codified at 21 C.F.R. § 862.1660. |
| Predicate Device | Maine Standards Company VALIDATE CHEM 3 Calibration Verification
Test Set |
| Intended Use | The Ischemia ACB® Assay Verification Set is intended for use in verifying
accuracy of the ACB Test on the Roche Integra 700/800. It is recommended as
a part of assay installation.
For In Vitro Diagnostic Use. |
| Technological
Characteristics | The Assay Verification Set consists of twenty (20) single vial 0.5 mL aliquots
of frozen serum based samples with assigned IMA values over the
physiological range. |
| Testing | The Assay Verification Set was evaluated for expiry date and for range setting
values internally and at multiple clinical sites. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an eagle with its wings spread, surrounded by a circle of text. The text reads "U.S. Department of Health & Human Services - USA". The eagle is a stylized representation, with three lines forming its body and wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 6 2006
Mr. James M. Delaney Director Regulatory Affairs Inverness Medical Innovations, Inc. 51 Sawyer Rd. Suite 200 Waltham, MA 02453-3448
,
IVIII
K060133 Re:
Trade/Device Name: The Ischemia Albumin Cobalt Binding Test (ACB®) Assay Verification Set Regulation Number: 21 CFR§ 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: January 16, 2006 Received: January 18, 2006
Dear Mr. Delaney:
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).
2
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) This icher will anow you to begal manies of substantial equivalence of your device to a legally promatics notification: "The PDF interestion 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, If you desire specific mostion and advertising of your device, please contact the Office of In of quostions on the promotion 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 Tou may other bally generational 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 vours,
Alberto Gutz
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
Indications for Use
510(k) Number (if known):
Device Name: The Ischemia Albumin Cobalt Binding Test (ACB®) Assay Verification Set
The Ischemia Albumin Cobalt Binding Test (ACB®) Assay Indications For Use: Indications For Use. - The Isonema I noveling accuracy of the ACB Test on the Roche Integra 700/800. It is recommended as a part of assay installation.
For In Vitro Diagnostic Use
X Prescription Use (Part 21 CFR 801 Subpart D) 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)
Ann Chappie
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_ K060133 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------