(52 days)
No
The summary describes a standard automated clinical chemistry analyzer and associated reagents, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is for in vitro diagnostic use, meaning it measures analytes in human specimens, which aids in diagnosis but does not directly treat or prevent disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "For in vitro diagnostic use only" and that "Measurement of urinary albumin aids in the diagnosis of diabetic nephropathy, hypertension and cardiovascular disease."
No
The device description clearly outlines a physical chemistry analyzer system (VITROS 5,1 FS Chemistry System) that utilizes various physical reagents (liquid and dry) to perform in vitro diagnostic tests. While software is undoubtedly part of the system's operation, the core device is a hardware-based analyzer, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" multiple times for the reagents and calibrator.
- Purpose: The device is used to "quantitatively measure albumin concentration in human urine" to "aid in the diagnosis of diabetic nephropathy, hypertension and cardiovascular disease." This is a classic example of an in vitro diagnostic test.
- Device Description: The description details a "fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens." This further confirms its IVD nature.
- Components: The components listed (reagents, calibrators, controls) are all typical elements of an in vitro diagnostic system.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only. VITROS Chemistry Products mALB Reagent is used to quantitatively measure albumin concentration in human urine (mALB). Measurement of urinary albumin aids in the diagnosis of diabetic nephropathy, hypertension and cardiovascular disease.
For in vitro diagnostic use. VITROS Chemistry Products Calibrator Kit 24 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of albumin in urine (mALB).
For in vitro diagnostic use only. VITROS Chemistry Products mALB Performance Verifiers are assayed controls used to monitor the performance of mALB Reagent on VITROS 5,1 FS Chemistry Systems.
Product codes
DCF, JJX, JIT
Device Description
The VITROS 5,1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS System is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.
The system is comprised of four main elements:
- The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5,1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
- The VITROS Chemistry Products MicroTip range of liquid reagent products (in this case VITROS Chemistry Products mALB Reagent, VITROS Chemistry Products Calibrator Kit 24 and VITROS Chemistry Products mALB Performance Verifiers I and II), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS mALB assay.
- The VITROS Chemistry Products Thin Film range of dry products, which are dry, multilayered, analytical elements, coated on polyester supports. The thin film products each have their own 510(k) clearance numbers and were cleared for market for use on the VITROS 5,1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers''. The required information was provided in the VITROS 5,1 FS Chemistry System premarket notification (K031924).
- Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of 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)
Correlation studies were performed to determine the precision, analytical sensitivity, specificity and expected values of the VITROS mALB assay.
The relationship between the VITROS mALB assay and the predicate device (N Antiserum to Human Albumin assay on the Dade Behring BN ProSpec System), determined by the Passing & Bablock linear regression is: VITROS mALB assay = 0.93x + 0.03, with a correlation coefficient of 0.977.
Equivalence to the predicates was demonstrated using commercially available reagents along with patient samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5040 Albumin immunological test system.
(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(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 § 866.9.
0
NOV 1 8 2004
3.0 510(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: _ KO 2 2 4 3
3.1 Submitter name, address, contact
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 Phone: (585) 453-4253 Fax: (585) 453-3368
Contact Person: Darlene J. Phillips
3.2 Date of Preparation:
September 24, 2004
3.3 Device Proprietary Names:
VITROS Chemistry Products mALB Reagent Trade Names VITROS Chemistry Products Calibrator Kit 24 VITROS Chemistry Products mALB Performance Verifiers I and II Common Name Microalbumin assay
3.4 Classification Names
Classification Name: Albumin immunological test system (866.5040): Class: II (Special controls)
Classification Name: Calibrator (862.1150): Class II The Clinical Chemistry and Toxicology Panel of the FDA has placed calibrators in Class II.
Classification Name: Quality Control material (assayed and unassayed) (862.1660): Class I: The Clinical Chemistry and Toxicology Panel of the FDA has placed Quality Control material (assayed and unassayed) for clinical chemistry in Class I. Since this device is an assayed control, it meets the reserved criteria under Section 510(1) of the Food, Drug, and Cosmetic Act.
Continued on next page
:
1
3.5 Predicate device
- 3.5.1 The VITROS Chemistry Products mALB Reagent and VITROS Chemistry Products Calibrator Kit 24 are substantially equivalent to the N Antiserum to Human Albumin assayed on the Dade Behring BN System.
- 3.5.2 The VITROS Chemistry Products mALB Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Performance Verifiers I and II.
3.6 Device description
The VITROS 5,1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS System is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.
The system is comprised of four main elements:
- The VITROS 5,1 FS Chemistry System instrumentation, which provides automated 1 use of the chemistry reagents. The VITROS 5,1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
- 2 The VITROS Chemistry Products MicroTip range of fiquid reagent products (in this case VITROS Chemistry Products mALB Reagent, VITROS Chemistry Products Calibrator Kit 24 and VITROS Chemistry Products mALB Performance Verifiers I and II), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS mALB assay.
- The VITROS Chemistry Products Thin Film range of dry products, which are dry, 3 multilayered, analytical elements, coated on polyester supports. The thin film products each have their own 510(k) clearance numbers and were cleared for market for use on the VITROS 5,1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers''. The required information was provided in the VITROS 5,1 FS Chemistry System premarket notification (K031924).
-
- Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
Continued on next page
2
3.7 Device intended use
3.7.1 VITROS Chemistry Products mALB Reagent
For in vitro diagnostic use only. VITROS Chemistry Products mALB Reagent is used to quantitatively measure albumin concentration in human urine (mALB).
3.7.2 VITROS Chemistry Products Calibrator Kit 24
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 24 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of albumin.
3.7.3 VITROS Chemistry Products mALB Performance Verifiers I and II
For in vitro diagnostic use only. VITROS Chemistry Products mALB Performance Verifiers are assayed controls used to monitor the performance of mALB Reagent on VITROS 5,1 FS Chemistry Systems.
3.8 Comparison to predicate device
- 3.8.1 The VITROS Chemistry Products mALB Reagent and VITROS Chemistry Products Calibrator Kit 24 are substantially equivalent to the N Antiserum to Human Albumin assay on the Dade Behring BN ProSpec System (predicate device) which was cleared by the FDA (K972929) for IVD use.
The relationship between the VITROS mALB assay and the predicate device, determined by the Passing & Bablock linear regression is:
VITROS mALB assay = 0.93x + 0.03
with a correlation coefficient of 0.977,
where X is the result for the N Antiserum to Human Albumin assay on the Dade Behring BN ProSpec System.
In addition to the above mentioned correlation studies were performed to determine the precision, analytical sensitivity, specificity and expected values of the VITROS mALB assay, (refer to VITROS mALB Reagent Instructions For Use in Section 8 for summaries of the results of these studies).
Continued on next page
3
| Table 1 | Table 1 lists the characteristics of the VITROS mALB assay (new device) and the Dade N |
|---|---|
| Antiserum to Human Albumin assay (predicate device). |
| Device
Characteristic | VITROS mALB assay
(New Device) | Dade Albumin assay
(Predicate Device) |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only.
VITROS Chemistry Products mALB
Reagent is used to quantitatively
measure albumin concentration in
human urine (mALB). | In vitro diagnostic reagents for the
quantitative determination of albumin
in human urine using the BN
Systems. |
| Method | Immunoturbidimetry | Rate nephelometry |
| Reportable Range | 0.6 to 19.0 mg/dL | 0.0 to 34.0 mg/dL |
| Instrumentation | VITROS 5,1 FS Chemistry Systems | Dade Behring BN ProSpec Systems |
| Sample type | Urine | Urine |
| Reactive Ingredient | Goat anti-sera to human albumin | Rabbit antiserum to human albumin |
3.8.2 The VITROS Chemistry Products mALB Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Performance Verifiers (predicate device) which were cleared by the FDA (K041720) for IVD use.
- Table 2 lists the similarities and differences of the device characteristics between the VITROS Table 2 mALB Performance Verifiers with the predicate device, VITROS Performance Verifiers I and II.
| Device
| Characteristic | New device | Predicate device |
|---|---|---|
| Intended Use | For in vitro diagnostic use only. | |
| VITROS Chemistry Products mALB | ||
| Performance Verifiers are assayed | ||
| controls used to monitor the | ||
| performance of mALB Reagents on | ||
| VITROS 5,1 FS Chemistry Systems. | For in vitro diagnostic use only. | |
| VITROS Performance Verifier is | ||
| an assayed control used to | ||
| monitor performance on VITROS | ||
| Chemistry Systems. | ||
| Fluid Matrix | A base matrix of processed human | |
| serum to which inorganic salt, | ||
| buffers, protein, surfactant and | ||
| preservative have been added. | A base matrix of freeze-dried | |
| human serum to which enzymes, | ||
| electrolytes, stabilizers, | ||
| preservatives and other organic | ||
| analytes have been added. | ||
| Analyte Levels | Low and High | Low and High |
3.9 Conclusions
The data presented in the premarket notification provide a reasonable assurance that the VITROS mALB assay and the VITROS Chemistry Products mALB Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices.
Equivalence to the predicates was demonstrated using commercially available reagents along with patient samples.
4
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 consists of a stylized eagle or bird-like symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged in a circular fashion around the left side of the emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 18 2004
Ms. Darlene J. Phillips, RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626-5101
Re: K042643
Trade/Device Name: VITROS Chemistry Products mALB Reagent VITROS Chemistry Products Calibrator Kit 24 VITROS Chemistry Products mALB Performance Verifiers I and II Regulation Number: 21 CFR 866.5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Code: DCF, JJX, JIT Dated: September 24, 2004 Received: September 27, 2004
Dear Ms. Phillips:
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).
5
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours.
Jean M. Cooper US. Div.
Tean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
1.0 Indications for Use
| 510(k) Number (if known): | K042643 |
|---|---|
| Device Name: | VITROS Chemistry Products mALB Reagent |
| VITROS Chemistry Products Calibrator Kit 24 | |
| VITROS Chemistry Products mALB Performance Verifiers I and II | |
| Indications for Use: | For in vitro diagnostic use only. |
| VITROS Chemistry Products mALB Reagent is used to quantitatively measure albumin concentration in human urine (mALB). Measurement of urinary albumin aids in the diagnosis of diabetic nephropathy, hypertension and cardiovascular disease. |
For in vitro diagnostic use.
VITROS Chemistry Products Calibrator Kit 24 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of albumin in urine (mALB).
For in vitro diagnostic use only.
VITROS Chemistry Products mALB Performance Verifiers are assayed controls used to monitor the performance of mALB Reagent on VITROS 5,1 FS Chemistry Systems. |
| Prescription Use
(Part 21 CFR 801 Subpart D) | ✓ AND/OR Over-The-Counter Use
(21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
and the comments of the comments of the country of the country of the country of the country of the country of the country of the country of the country of the country of the
Carol Benam
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
210(K) Koy2663
Page 1 of 1