(29 days)
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.
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.
This looks like a submission for a "Quality Control Material" device, not an AI or imaging device. The provided text describes a verification set for an assay, which is a laboratory test. Therefore, many of the requested fields are not applicable to this type of device.
However, I can extract the relevant information where possible:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" with numerical targets for the Assay Verification Set itself. Instead, it describes its intended use for verifying the accuracy of another device (the ACB Test) and its characteristics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 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. |
| Evaluation Purpose | The Assay Verification Set was evaluated for expiry date and for range setting values. |
| Evaluation Location | Internally and at multiple clinical sites. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: The device itself is the "test set" and consists of "twenty (20) single vial 0.5 mL aliquots of frozen serum based samples."
- Data provenance: Not specified, but the evaluation was done "internally and at multiple clinical sites."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a quality control material with "assigned IMA values." These values are likely laboratory-derived and not based on expert consensus in the way a diagnostic imaging device would be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. "Adjudication" typically refers to the process of resolving disagreements among experts when establishing ground truth, which is not relevant for a quality control material with assigned values.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a quality control material, not an AI or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device is described as "assigned IMA values over the physiological range." This implies laboratory-determined values for the components of the serum samples.
8. The sample size for the training set
Not applicable. This device is a quality control material, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this device does not have a training set in the context of machine learning.
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K 060/33
510(k) Summary
| Submitted by: | James M. DelaneyInverness Medical Innovations, Inc.51 Sawyer Rd., Ste. 200Waltham, MA 02453 |
|---|---|
| Prepared on: | January 12, 2006 |
| Device name | The Ischemia Albumin Cobalt Binding Test (ACB® Test) Assay VerificationSet |
| Classificationname | 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 andUnassayed). The device is codified at 21 C.F.R. § 862.1660. | |
| Predicate Device | Maine Standards Company VALIDATE CHEM 3 Calibration VerificationTest Set |
| Intended Use | The Ischemia ACB® Assay Verification Set is intended for use in verifyingaccuracy of the ACB Test on the Roche Integra 700/800. It is recommended asa part of assay installation.For In Vitro Diagnostic Use. |
| TechnologicalCharacteristics | The Assay Verification Set consists of twenty (20) single vial 0.5 mL aliquotsof frozen serum based samples with assigned IMA values over thephysiological range. |
| Testing | The Assay Verification Set was evaluated for expiry date and for range settingvalues internally and at multiple clinical sites. |
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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).
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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
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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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
§ 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.