(28 days)
No
The summary describes a system for verifying calibration using luminescence and coated microwells, with no mention of AI or ML technologies in the device description, intended use, or performance studies.
No
This device is for in vitro use in verifying the calibration range of a diagnostic system, not for direct therapeutic treatment on a patient.
No
The device (VITROS Immunodiagnostic Products Range Verifiers) is intended for verifying the calibration range of the VITROS Immunodiagnostic System, not for directly diagnosing medical conditions in patients. It is used to ensure the accuracy of another diagnostic system.
No
The device description clearly outlines hardware components (VITROS ECi Immunodiagnostic System instrumentation, coated microwells, reagent packs, calibrators, range verifiers) and is for in vitro use, indicating a physical laboratory system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of Vitamin B12." The phrase "in vitro use" is a key indicator of an IVD.
- Device Description: The description details its use with the VITROS Immunodiagnostic System for the "quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine." This describes testing performed outside of the body on biological samples, which is the definition of in vitro diagnostics.
- Product Name: The product is called "VITROS Immunodiagnostic Products Range Verifiers," and it is used with "VITROS Immunodiagnostic Products Reagent Pack and VITROS Immunodiagnostic Products Calibrators." The term "Immunodiagnostic Products" strongly suggests an IVD.
- Predicate Device: The predicate device is also named "VITROS Immunodiagnostic Products Vitamin B12 Range Verifiers," further reinforcing its classification as an IVD.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of Vitamin B12.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
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, plasma and urine. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
-
- The VITROS ECi Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Range Verifiers, which are used along with VITROS Immunodiagnostic Products Reagent Pack and VITROS Immunodiagnostic Products Calibrators by the VITROS ECi Immunodiagnostic System to verify the performance of the VITROS assay).
-
- The VITROS ECi Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS ECi System was cleared for market by a separate 510(k) pre-market notification (K962919).
-
- Common reagents used by the VITROS ECi System in each assay. The VITROS Common rougents asocures Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K964310).
The VITROS ECi System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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: _KO13900
1. Submitter name, address, contact
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (716) 453-4041
Contact Person: Marlene A. Shulman
Date 510(k) prepared: November 21, 2001
2. Device Name
Trade or Proprietary Name: VITROS Immunodiagnostic Products Vitamin B12 Range Verifiers
Common Name: Range Verifiers
Classification Name: VITROS Range verifiers for use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include Vitamin B12.
3. Predicate Device
The VITROS Immunodiagnostic Products Vitamin B12 Range Verifiers are substantially equivalent to VITROS Immunodiagnostic Products Vitamin B12 Range Verifiers (K990026).
4. Device Description
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, plasma and urine. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
-
- The VITROS ECi Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Range Verifiers, which are used along with VITROS Immunodiagnostic Products Reagent Pack and VITROS Immunodiagnostic Products Calibrators by the VITROS ECi Immunodiagnostic System to verify the performance of the VITROS assay).
1
510(k) Summary, Continued.
-
- The VITROS ECi Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS ECi System was cleared for market by a separate 510(k) pre-market notification (K962919).
-
- Common reagents used by the VITROS ECi System in each assay. The VITROS Common rougents asocures Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K964310).
The VITROS ECi System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
5. Device Intended Use
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of Vitamin B12.
6. Comparison to Predicate Device
The VITROS Immunodiagnostic Products Range Verifiers are substantially equivalent to VITROS Vitamin B12 Range Verifiers (predicate device), which was approved by FDA (K990026) for IVD use.
Table 1 lists the similarities and differences of the device characteristics between the VITROS Vitamin B12 Range Verifiers with the predicate device, previously-cleared VITROS Vitamin B12 Range Verifiers.
Continued on next page
2
510(k) Summary, Continued
Table 1 List of the assay characteristics
| Characteristics | New Device | Predicate Device |
|---|---|---|
| Intended use | For use in verifying the calibration | |
| range of the VITROS | ||
| Immunodiagnostic System when | ||
| used for the measurement of | ||
| Vitamin B12. | For use in verifying the calibration | |
| range of the VITROS | ||
| Immunodiagnostic System when | ||
| used for the measurement of | ||
| Vitamin B12. | ||
| Matrix of Range | ||
| Verifiers | Buffered matrix containing liquid | |
| human serum albumin | Buffered matrix containing liquid | |
| human serum albumin | ||
| Range Verifier levels | Low: | |
| Target Concentration: in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of Vitamin B12. |
Page 1 of 1(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K013900
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ ← (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Qptional Format 1-2-96)