(28 days)
Not Found
No
The device is a chemical standard for calibrating an assay, not a software or imaging device, and the summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is described as an "Iron Standard" used for calibration of quantitative assays, not for diagnostic, treatment, or preventative purposes in patients.
No
The device, "Iron Standard," is described as being "for use in the calibration of quantitative Unsaturated Iron Binding Capacity (UIBC) assays." Calibration standards are used to ensure the accuracy of a diagnostic device (the assay), but they are not diagnostic devices themselves as they do not directly perform the diagnosis.
No
The device description clearly states it is an aqueous solution, which is a physical substance, not software.
Based on the provided information, the Iron Standard is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's "for use in the calibration of quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers." Calibration materials used in diagnostic assays are considered IVDs.
- Device Description: It's a reagent (aqueous solution) used in a laboratory setting for a diagnostic test.
- Intended User/Care Setting: It's used with "Roche clinical chemistry analyzers," which are instruments used for performing in vitro diagnostic tests in a clinical setting.
- Predicate Device: The mention of a predicate device (K033873; Elecsys® C-Peptide Calset) strongly suggests that this device is also subject to regulatory review as an IVD. Predicate devices are used to demonstrate substantial equivalence for new IVD submissions.
While the document doesn't explicitly state "This is an IVD," all the characteristics and context point to it being a product intended for use in an in vitro diagnostic procedure.
N/A
Intended Use / Indications for Use
"Iron Standard is for use in the calibration of quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers."
Product codes
JIT
Device Description
"The Iron Standard is a single-level product consisting of a gravimetrically prepared aqueous solution of Ferrous Ammonium Sulfate Hexahydrate."
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Elecsys® C-Peptide Calset (K033873)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
AUG 2 2 2005
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|---|---|
| Submitter's name, address, and contact | Roche Diagnostics |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| 317-521-3831 | |
| Contact Person: Corina Harper | |
| Date Prepared: July 22, 2005 | |
| Device name | Proprietary name: Iron Standard |
| Common name: Calibrator | |
| Classification name: Calibrator, Secondary, Class II | |
| Predicate device | The Iron Standard is substantially equivalent to the currently marketed Elecsys® C-Peptide Calset (K033873). |
| Device description | The Iron Standard is a single-level product consisting of a gravimetrically prepared aqueous solution of Ferrous Ammonium Sulfate Hexahydrate. |
| Intended use | Iron Standard is for use in the calibration of quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers. |
| Continued on next page |
1
510(k) Summary, Continued
| Substantial
equivalence:
Similarities | The Iron Standard is substantially equivalent to the currently marketed
Elecsys® C-Peptide Calset (K033873). The below tables compare Iron
Standard with the predicate device, Elecsys® C-Peptide Calset. |
| --------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Characteristic | Iron Standard | Predicate Device
Elecsys® C-Peptide
Calset (K033873) |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the
calibration of
quantitative
Unsaturated Iron
Binding Capacity
(UIBC) assays on
Roche clinical
chemistry analyzers. | For calibrating the
quantitative Elecsys®
C-Peptide assay on the
Elecsys® immunoassay
systems. |
| Levels | One | Two |
:
,
Continued on next page
2
510(k) Summary, Continued
Substantial equivalence: Differences
The below tables compare Iron Standard with the predicate device, Elecsys® C-Peptide Calset.
の 2007年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には1000年に1000000000000000000000000000000000000000000000000000000
| Characteristic | Iron Standard | Predicate Device
Elecsys® C-Peptide
Calset (K033873) |
|----------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Format | Aqueous solution | Lyophilized |
| Handling | Ready to use | Add exactly 1.0 ml distilled water and allow to stand closed for 15 minutes to reconstitute. Mix carefully, avoiding the formation of foam. |
| Stability | Unopened:
• Store at 15-25°C until expiration date
After opening:
• 15-25°C: until expiration date | Unopened:
• Store at 2-8°C until expiration date
Reconstituted:
• -20°C: 1 month (freeze only once)
• On the analyzers at 20-25°C: use only once |
| | Matrix | Gravimetrically prepared aqueous solution of Ferrous Ammonium Sulfate Hexahydrate. |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
DEPARTMENT OF HEALTH & HUMAN SERVICES USA
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 2 2005
Ms. Corina Harper, RAC Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250
Re: K052002
Trade/Device Name: Iron Standard Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: July 22, 2005 Received: July 25, 2005
Dear Ms. Harper:
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).
4
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter mif anony you we 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 information about the application of labeling requirements to your device, n you don't on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation 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 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/industry/support/index.html.
Sincerely yours,
Carol C. Benson
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Iron Standard
Indications For Use:
Iron Standard is for use in the calibration of quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers.
Koszood
Prescription Use XXXX (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)
Division Sign-Off
| Roche Diagnostics Confidential | Office of In Vitro Diagnostic Device Evaluation and Safety |
|---|---|
| 510(k) | K052002 |
| 14 | |
|---|---|
| -- | ---- |