(23 days)
The IMMULITE 2500 Vitamin B12 assay is for in vitro diagnostic use with the IMMULITE 2500 Analyzer — for the quantitative measurement of vitamin B12 in serum or heparinized plasma, as an aid in clinical diagnosis and treatment of anemia.
The IMMULITE 2500 Folic Acid is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.
IMMULITE 2500 Vitamin B12 is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.
IMMULITE 2500 Folic Acid is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.
The provided text is a 510(k) summary for the IMMULITE 2500 Vitamin B12 and IMMULITE 2500 Folic Acid assay. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical study data with specific acceptance criteria and detailed performance statistics as might be found in a PMA submission or a full clinical study report.
Therefore, the document does not contain the detailed information required to fill out all sections of your request. Specifically, it lacks:
- Explicit acceptance criteria: While the claim of "substantial equivalence" implies that performance is comparable to the predicate, specific quantitative acceptance criteria for each analytical performance parameter are not listed.
- Detailed study results (test set sample size, provenance, ground truth establishment, expert details, adjudication methods, MRMC studies, standalone performance): The summary states the conclusion of substantial equivalence based on information presented in the Special 510(k), but it doesn't provide the raw data, study design, or methodology for how that equivalence was demonstrated in terms of clinical performance or specific analytical studies for new aspects of the device. Special 510(k)s often refer to changes that do not affect the intended use or fundamental scientific technology, relying on previous data and analytical verification.
- Training set details: Information on a separate training set is not present as this is typically required for AI/ML device submissions, which this is not.
Based on the information available:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the given 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device (IMMULITE 2000 Vitamin B12 and IMMULITE 2000 Folic Acid), implying that its performance is critically comparable to that predicate. Specific numerical acceptance criteria and detailed performance results of verification and validation studies are not included in this summary document. Performance data would typically be found in the manufacturer's internal validation reports, which are not publicly available in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the given 510(k) summary.
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):
This information is not applicable as this device is an in-vitro diagnostic test for quantitative measurement of biomarkers, not an imaging device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as this device is an in-vitro diagnostic test.
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:
This information is not applicable. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable in the context of an "algorithm only" performance for an IVD test in the same way it would be for an AI/ML device. The device's performance is intrinsically standalone as it quantitatively measures a biomarker. The summary implies the device's analytical performance (accuracy, precision, linearity, etc.) was assessed, but details are not provided here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For an in-vitro diagnostic device like IMMULITE 2500 Vitamin B12, the "ground truth" would typically refer to the true concentration of Vitamin B12 in a sample. This "ground truth" is usually established through:
- Reference Methods: Comparison against established, highly accurate reference methods, often involving mass spectrometry or validated laboratory methods.
- Certified Reference Materials: Using materials with known, accurately assigned concentrations of the analyte.
- Spiked Samples: Samples artificially augmented with known amounts of the analyte.
The specific methods used to establish this "ground truth" for the performance studies are not detailed in this 510(k) summary.
8. The sample size for the training set:
This information is not provided/not applicable for this type of IVD device in the context of AI/ML training data.
9. How the ground truth for the training set was established:
This information is not provided/not applicable for this type of IVD device in the context of AI/ML training data.
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K0600929
IMMULITE 2500 Vitamin B12
113 28 276
510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
| Name: | Diagnostic Products Corporation (DPC) |
|---|---|
| Address: | 5210 Pacific Concourse DriveLos Angeles, California 90045-6900 |
| Telephone Number: | (310) 645-8200 |
| Facsimile Number: | (310) 645-9999 |
| Contact Person: | Deborah L. MorrisDirector, Clinical Affairs & Regulatory Submissions |
| Date of Preparation: | April 4, 2006 |
| Device Name:Trade: | IMMULITE® 2500 Vitamin B12 |
| Catalog Number: | L5KVB |
| 21 CFR 862.1810: | A vitamin B12 test system is a device intended to measurevitamin B12 in serum, plasma, and urine. Measurements obtainedby this device are used in the diagnosis and treatment of anemiasof gastrointestinal malabsorption. |
| Common: | Vitamin B12 test system |
| Classification: | Class II device; Product Code: CDD (21 CFR 862.1810) |
| Panel: | Clinical Chemistry |
| CLIA Complexity Category: | We believe the category to be moderate based on previousclassification of analogous tests. |
| Manufacturer: | Diagnostic Products Corporation (DPC)5700 West 96th StreetLos Angeles, California 90045-5597Diagnostic Products Corporation (DPC)5210 Pacific Concourse DriveLos Angeles, California 90045-6900 |
| Establishment RegistrationNumber: | DPC's Registration Numbers are: |
| Diagnostic Products Corporation (DPC)5700 West 96th Street | |
| Los Angeles, California 90045-5597Registration #: 2017183 | |
| Diagnostic Products Corporation (DPC)5210 Pacific Concourse Drive | |
| Los Angeles, California 90045-6900Registration #: 3005250747 | |
| SubstantiallyEquivalent | |
| Predicate Device: | IMMULITE 2000 Vitamin B12 (K993251) |
| Description of Device: | IMMULITE 2500 Vitamin B12 is a solid-phase, two-sitechemiluminescent enzyme immunoassay for use with theIMMULITE 2500 Automated Analyzer. |
0009 ***
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Intended Use of the Device: The IMMULITE 2500 Vitamin B12 is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of vitamin B12 in serum or heparinized plasma, as an aid in clinical diagnosis and treatment of anemia.
Conclusion:
The information presented in this Special 510(k) is that which the Food and Drug Administration used in granting Diagnostic Products Corporation substantial equivalence for IMMULITE 2500 Viramin B12.
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IMMULITE 2500 Folic Acid 510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
| Name: | Diagnostic Products Corporation (DPC) |
|---|---|
| Address: | 5210 Pacific Concourse DriveLos Angeles, California 90045-6900 |
| Telephone Number: | (310) 645-8200 |
| Facsimile Number: | (310) 645-9999 |
| Contact Person: | Deborah L. MorrisDirector, Clinical Affairs & Regulatory Submissions |
| Date of Preparation: | April 4, 2006 |
| Device Name:Trade: | IMMULITE® 2500 Folic Acid |
| Catalog Number: | L5KFO |
| 21 CFR 862.1295: | A folic acid test system is a device intended to measure thevitamin folic acid in plasma and serum. Folic acid measurementsare used in the diagnosis and treatment of megaloblastic anemia,which is characterized by the presence of megaloblasts (anabnormal red blood cell series) in the bone marrow. |
| Common: | Folic Acid test system |
| Classification: | Class II device; Product Code: CGN (21 CFR 862.1295) |
| Panel: | Clinical Chemistry |
| CLIA ComplexityCategory: | We believe the category to be moderate based on previousclassification of analogous tests. |
| Manufacturer: | Diagnostic Products Corporation (DPC)5700 West 96th StreetLos Angeles, California 90045-5597Diagnostic Products Corporation (DPC)5210 Pacific Concourse DriveLos Angeles, California 90045-6900 |
0000160
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| Establishment Registration Number: | |
|---|---|
| ------------------------------------ | -- |
DPC's Registration Numbers are:
| Diagnostic Products Corporation (DPC)5700 West 96th StreetLos Angeles, California 90045-5597Registration #: 2017183 | |
|---|---|
| Diagnostic Products Corporation (DPC)5210 Pacific Concourse DriveLos Angeles, California 90045-6900Registration #: 3005250747 |
| Substantially Equivalent Predicate Device: | IMMULITE 2000 Folic Acid (K993254) |
|---|---|
| Description of Device: | IMMULITE 2500 Folic Acid is a solid-phase, two-sitechemiluminescent enzyme immunoassay for use with theIMMULITE 2500 Automated Analyzer. |
Intended Use of the Device: The IMMULITE 2500 Folic Acid is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.
Conclusion:
The information presented in this Special 510(k) is that which the Food and Drug Administration used in granting Diagnostic Products Corporation substantial equivalence for IMMULITE 2500 Folic Acid.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 8 2006
Ms. Deborah L. Morris Director of Clinical Affairs & Regulatory Submissions Diagnostic Products Corporation 5210 Pacific Concourse Drive Los Angeles CA 90045
Re: K060929
Trade/Device Name: IMMULITE 2500 Vitamin B12 IMMULITE 2500 Folic Acid Regulation Number: 21 CFR§862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: Class II Product Code: CDD, CGN Dated: April 4, 2006 Received: April 5, 2006
Dear Ms. Morris:
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) 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 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 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 vours.
Alberto G.
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
510(k) Number (if known):
IMMULITE 2500 Vitamin B12 Device Name:
Indications For Use:
The IMMULITE 2500 Vitamin B12 assay is for in vitro diagnostic use with the IMMULITE 2500 Analyzer — for the quantitative measurement of vitamin B12 in serum or heparinized plasma, as an aid in clinical diagnosis and treatment of anemia.
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)
Division
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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Nasional programma
Cara Cara
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Indications for Use
K060929 510(k) Number (if known):
IMMULITE 2500 Folic Acid Device Name:
Indications For Use:
The IMMULITE 2500 Folic Acid is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.
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)
C.J.C.
Division Sign-Off
Office of In Vitm Diagnostic Device Evaluation and Safety
1083 K060929
Page 1 of
§ 862.1810 Vitamin B
12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.