(62 days)
1 & 2. The VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 and the VITROS Immunodiagnostic Products Vitamin B12/ Folate Reagent Pack 3 quantitatively measures vitamin B12 concentration in human serum and plasma (EDTA or heparin), to aid in the diagnosis of anemia using the VITROS ECi Immunodiagnostic System with Intellicheck.
- The VITROS Immunodiagnostic Products Vitamin B12 Calibrators- for use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin).
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
- The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/ 2, VITROS Immunodiagnostic Products Vitamin B12/ Folate Reagent Pack 3, Vitros Immunodiagnostic Products Vitamin B12 Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Vitamin B12 assay.
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) premarket notification (K962919).
- Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
I am sorry, but based on the provided text, I cannot extract the specific acceptance criteria and the detailed study results that prove the device meets these criteria in the format you requested.
The document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed breakdown of acceptance criteria and a standalone study report against those criteria.
Here's what I can tell you based on the document and why I cannot fulfill your request completely:
- No explicit acceptance criteria table: The document does not provide a table of pre-defined acceptance criteria (e.g., specific thresholds for precision, sensitivity, etc.) that the device needed to meet.
- Study is for substantial equivalence, not standalone performance against acceptance criteria: The primary study described is a comparison study to a predicate device (BECKMAN Access Vitamin B12 assay) to establish substantial equivalence. It's not a study designed to prove the device meets pre-defined acceptance criteria for its performance characteristics in isolation.
- Limited detail on individual study results: While it mentions "studies were performed to determine the precision, analytical sensitivity, specificity and expected values," it specifically states to "refer to the VITROS Vitamin B12 Assay Test Methodology Sheet for summaries of the results of these studies." This detailed information is not included in the provided text.
Here's a breakdown of what is available in the document regarding the device and its evaluation:
1. A table of acceptance criteria and the reported device performance:
* Acceptance Criteria: Not explicitly stated as a separate table with specific targets.
* Reported Device Performance (from comparison study):
* Relationship to Predicate Device: VITROS Vitamin B12 assay = 1.028 x X - 9.34 (pg/mL), where X is BECKMAN Access Vitamin B12 Assay.
* Correlation Coefficient: 0.943
2. Sample size used for the test set and the data provenance:
* Test Set Sample Size: Not explicitly stated. The document mentions "a panel of patient samples from a variety of clinical categories."
* Data Provenance: "patient samples from a variety of clinical categories." No specific country of origin is given. The study appears retrospective as it's comparing the new device against a legally marketed predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This information is not provided in the document. For diagnostic assays like this, "ground truth" would typically come from a reference method or clinical diagnosis, not necessarily "experts" in the way you might define them for image interpretation.
4. Adjudication method for the test set:
* Not applicable as the ground truth establishment method (if any beyond the predicate device's measurement) is not detailed. The comparison is between the new device's measurements and the predicate device's measurements.
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 is not applicable to an in-vitro diagnostic (IVD) assay for vitamin B12. MRMC studies are typically for image interpretation tasks where human readers are involved. This device automates the measurement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* Yes, the device itself is a standalone automated assay. The studies conducted (precision, analytical sensitivity, specificity, expected values) would inherently be evaluating its standalone performance. However, the results of these standalone studies are not provided in detail within the summary, only referenced as existing in a separate "Test Methodology Sheet."
7. The type of ground truth used:
* For the comparison study: The predicate device's measurements (BECKMAN Access Vitamin B12 Assay) served as the comparative reference.
* For other studies (precision, sensitivity, specificity): The implicit ground truth would be against known concentrations of vitamin B12 in spiked samples or against a more definitive reference method, though this is not explicitly detailed.
8. The sample size for the training set:
* This is not a machine learning device in the contemporary sense that would have a "training set" for an algorithm. It's an immunoassay. The development and calibration of such assays involve various samples, but they aren't typically referred to as a "training set" in this context.
9. How the ground truth for the training set was established:
* Not applicable for a chemical immunoassay in the context of a "training set."
In summary, the provided 510(k) document is a high-level summary focused on demonstrating substantial equivalence. It refers to detailed performance studies but does not provide the granular data you are requesting for acceptance criteria and specific study results.
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JAN 2 4 2002
Chapter 1 - Summary Information
510(k) Summary
:
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: KO13899
- Submitter Ortho-Clinical Diagnostics, Inc. name, 100 Indigo Creek Drive address, Rochester, New York 14626-5101 contact (716) 453-4041
Contact Person: Marlene A. Shulman
-
- Preparation Date 510(k) prepared: November 20, 2001 date
- Trade or Proprietary Name: 3. Device name VITROS Immunodiagnostic Products Vitamin B12 Assay VITROS Immunodiagnostic Products Vitamin B12 Calibrators
Common Name: Vitamin B12 assay Classification Name: Vitamin B12 test system (862.1810)
The VITROS Immunodiagnostic Products Vitamin B12 Assay is substantially 4. Predicate device equivalent to the BECKMAN Access Vitamin B12 assay (K933142).
Continued on next page
VITROS Immunodiagnostic Products Vitamin B12 Assay
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-
The VITROS Immunodiagnostic System uses luminescence as the signal in 5. Device the quantitative and semi-quantitative determination of selected analytes in description human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements: -
- The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/ 2, VITROS Immunodiagnostic Products Vitamin B12/ Folate Reagent Pack 3, Vitros Immunodiagnostic Products Vitamin B12 Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Vitamin B12 assay.
-
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) premarket notification (K962919).
-
- Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
Continued on next page
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- The VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/ 2 6. Device and the VITROS Immunodiagnostic Products Vitamin B12/ Folate Reagent intended Pack 3 quantitatively measures vitamin B12 concentration in human serum use and plasma (EDTA or heparin), to aid in the diagnosis of anemia using the VITROS ECi Immunodiagnostic System with Intellicheck.
- The VITROS Immunodiagnostic Products Vitamin B12 Assay is 7. Comparison substantially equivalent to the BECKMAN Access Vitamin B12 assay to predicate (predicate device) which was cleared by the FDA (K933142) for IVD use. device
The relationship between the VITROS Vitamin B12 assay and the predicate device, determined by Deming's Regression, is:
VITROS Vitamin B12 assay = 1.028 x X - 9.34 (pg/mL), with a correlation coefficient of 0.943, where X is BECKMAN Access Vitamin B12 Assay.
This relationship was determined from a panel of patient samples from a variety of clinical categories.
In addition to the above mentioned correlation study, studies were performed to determine the precision, analytical sensitivity, specificity and expected values of the VITROS Vitamin B12 assay, (refer to the VITROS Vitamin B12 Assay Test Methodology Sheet for summaries of the results of these studies).
Table 1 lists the characteristics of the assays performed using the VITROS Vitamin B12 assay and the BECKMAN Access Vitamin B12 assay.
Continued on next page
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-
- Comparison Table 1 to predicate device,
Continued
- Comparison Table 1 to predicate device,
| DeviceCharacteristic | VITROS Vitamin B12assay | Predicate Device |
|---|---|---|
| Calibration range | 0-1000 pg/mL | 0-1500 pg/mL |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay |
| Tracer | Enzyme labeled | Enzyme-labeled |
| Binding Protein | Porcine Intrinsic Factor-biotinylated intrinsicfactor conjugate | Porcine Intrinsic Factor-alkaline phosphotaseconjugate |
| Instrumentation | VITROSImmunodiagnosticSystem | BECKMAN AccessImmunoassay System |
| Sample type | Serum and plasma(EDTA or heparin). | Serum and plasma(heparin). |
| Sample volume | 30μL | 45μL |
| Incubation time andtemperature | 48 minutes at 37°C | 30 minutes at 36.5 °C |
Continued on next page
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The data presented in the pre-market notification demonstrate that the 8. Conclusions performance of the VITROS Vitamin B12 assay is substantially equivalent to the cleared predicate device.
Equivalence was demonstrated using currently commercially available reagents along with patient samples covering a variety of clinical categories.
The data presented in the premarket notification provide a reasonable assurance that the VITROS Vitamin B12 assay is safe and effective for the stated intended use.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Marlene A. Shulman Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. Regulatory Affairs MC00882 100 Indigo Creek Drive Rochester, NY 14626-5101
JAN 2 4 2002
Re: K013899
Trade/Device Names: Vitros Immunodiagnostic Products Vitamin B12 Reagent Pack1/2 Vitros Immunodiagnostic Products VitaminB12/ Folate Reagent Pack 3
Vitros Immunodiagnostic Products Vitamin B12 Calibrators Regulation Number: 21 CFR 862.1810; 21 CFR 862.1810; 21 CFR 862.1150 Regulation Name: Vitamin B12 test system; Vitamin B12 test system; Calibrator Regulatory Class: Class II; Class II; Class II Product Code: CDD; CDD; JIS Dated: November 21, 2001 Received: November 23, 2001
Dear Ms. Shulman:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
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 nredicate 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 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/odrh/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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Statement of Intended Use
| Page 1 of 1 | |
|---|---|
| 510(k) Number (if known): | K013899 |
| Device Name: | 1. VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/22. VITROS Immunodiagnostic Products Vitamin B12/ Folate Reagent Pack 33. VITROS Immunodiagnostic Products Vitamin B12 Calibrators |
| Indications for Use: | 1 & 2. The VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 and the VITROS Immunodiagnostic Products Vitamin B12/ Folate Reagent Pack 3 quantitatively measures vitamin B12 concentration in human serum and plasma (EDTA or heparin), to aid in the diagnosis of anemia using the VITROS ECi Immunodiagnostic System with Intellicheck.3. The VITROS Immunodiagnostic Products Vitamin B12 Calibrators- for use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin). |
| (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF |
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K013899 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use | ||
|---|---|---|---|---|
| ------------------------------------------ | -- | ---- | ---------------------- | -- |
(Optional Format 1-2-96)
§ 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.