(43 days)
No
The device description details a standard spectrophotometric chemical assay and calibration process. There is no mention of AI or ML in the intended use, device description, performance studies, or any other section.
No.
The device is used to measure homocysteine levels for diagnostic purposes, not to treat or cure a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "For in vitro diagnostic use only. VITROS Chemistry Products HCY Reagent is used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma. Serum and plasma homocysteine levels can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria." This directly indicates its role in diagnosis.
No
The device description clearly outlines physical components including reagent packs, calibrator kits, performance verifiers, diluent packs, and a clinical chemistry instrument (VITROS 5.1 FS Chemistry System). These are all hardware components necessary for the device's function.
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." for the reagent, calibrator, and performance verifiers.
- Purpose: The device is intended to "quantitatively measure total homocysteine (HCY) concentration in human serum and plasma." This measurement is used to "assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria." This clearly indicates the device is used to analyze biological samples in vitro (outside the body) to provide information for medical diagnosis and treatment.
- Components: The description details reagents, calibrators, and performance verifiers, which are all typical components of an in vitro diagnostic system used for laboratory testing.
- Methodology: The description of the assay process (spectrophotometric measurement of NADH conversion) is a standard laboratory technique for analyzing biological samples.
The entire description points to a system designed for laboratory testing of human biological samples to aid in medical diagnosis, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only. VITROS Chemistry Products HCY Reagent is used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma. Serum and plasma homocysteine levels can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 27 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of homocysteine (HCY).
For in vitro diagnostic use only. VITROS Chemistry Products HCY Performance Verifiers are assayed controls used to monitor performance of VITROS HCY Reagents on VITROS 5,1 FS Chemistry Systems.
Product codes
LPS, JIT, JJX
Device Description
The VITROS Chemistry Products HCY Reagent is used in conjunction with the VITROS Chemistry Products Calibrator Kit 27 and VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline) on VITROS 5,1 FS Chemistry Systems to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
The quantitative measurement of homocysteine (HCY) is performed using the VITROS Chemistry Products HCY Reagent in conjunction with the VITROS Chemistry Products Calibrator Kit 27 and on the VITROS 5,1 FS Chemistry Systems. The VITROS Chemistry Products HCY Reagent consists of two dual chambered reagent packs containing three ready-to- use liquid reagents. Disulfide linked homocysteine (oxidized forms) in the sample is reduced by Tris (2-Carboxyethyl) phosphine hydrochloride (TCEP) to form reduced homocysteine. Reduced homocysteine reacts with serine in the presence of cystathionine ß-synthase (CBS) to form L-cystathionine. L-cystathionine is broken down by cystathionine ß-lyase (CBL) to produce homocysteine, pyruvate and ammonia. Pyruvate is reduced to lactate by lactate dehydrogenase (LDH) using NADH as coenzyme. The concentration of HCY is directly proportional to the amount of NADH converted to NAD and is measured spectrophotometrically at 340 nm. Once a calibration has been performed, the HCY concentration in each unknown sample can be determined using the stored calibration curve and the measured absorbance obtained in the assay of the sample.
The VITROS Chemistry Products Calibrator Kit 27 are prepared from an aqueous solution containing amino acids and inorganic acid. These standards are used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of homocysteine (HCY).
The VITROS Chemistry Products HCY Performance Verifiers I, II and III are prepared from processed human serum to which amino acid and preservative have been added. These are assayed controls used to monitor performance of VITROS HCY Reagents on VITROS 5.1 FS Chemistry Systems.
The VITROS Chemistry Products FS Diluent Pack 2 (Saline/BSA) is a common reagent that is used by multiple assays on the VITROS 5,1 FS Chemistry System. This is a dual chambered package containing two ready-to-use liquid diluents. Diluent 1 is prepared from processed water to which inorganic salt has been added. Diluent 2 is prepared from processed water to which bovine serum albumin, inorganic salts and preservatives have been added.
The VITROS 5.1 FS Chemistry System is a clinical chemistry instrument that provides automated use of the VITROS Chemistry Products MicroTip® and MicroSlides® range of products. The VITROS 5,1 FS System was cleared for market by 510(k) premarket notification (K031924).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison to predicate devices: A least squares linear regression analysis demonstrated the following relationship: y = 0.98 x + 1.0 umol/L, with a correlation coefficient = 0.97 where y = results obtained using the VITROS Chemistry Products HCY assay and x = results obtained with the commercially available system BIO-RAD HOMOCYSTEINE by HPLC test in conventional/SI units (umol/L).
In addition to correlation studies, bench testing was performed to determine assay precision, linearity, specificity, expected values, limit of detection, dilution and specimen matrix of the VITROS HCY assay.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 1.0 umol/L
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1377 Urinary homocystine (nonquantitative) test system.
(a)
Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for Ortho-Clinical Diagnostics. The logo consists of a symbol on the left, followed by the text "Ortho-Clinical Diagnostics". The text is underlined.
Johnson-Johnson company
100 Indigo Creek Drive Rochester, New York 14626-5101
510(k) Summary
JUL 2 1 2006
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:
- Ortho-Clinical Diagnostics, Inc. 1. Submitter 100 Indigo Creek Drive name, address, Rochester, New York 14626-5101 contact (585) 453-3143 Contact Person: Michael Byrne
- June 1, 2006 2. Preparation Date
Trade or Proprietary Names: 3. Device name
VITROS Chemistry Products HCY Reagent VITROS Chemistry Products Calibrator Kit 27 VITROS Chemistry Products HCY Performance Verifiers I, II & III
Common Names:
HCY assay and controls
Classification Names:
Urinary homocystine (nonquantitative) test system (21 CFR 862.1377) Class II Calibrators (21 CFR 862.1150) Class II Quality Control material (assayed and unassayed) (21 CFR 862.1660) Class I (general controls). Since these devices (HCY Performance Verifiers I, II & III) are assayed controls, they meet the reserved criteria under Section 510(I) of the Food, Drug, and Cosmetic Act.
Continued on next page
1
510(k) Summary (continued)
-
- Predicate The VITROS Chemistry Products HCY assay is substantially equivalent to the previously cleared BIO-RAD® HOMOCYSTEINE by HPLC test (K993107). Devices
The VITROS Chemistry Products HCY Performance Verifiers are substantially equivalent to the previously cleared VITROS Chemistry Products AAT Performance Verifiers (K052819).
- Predicate The VITROS Chemistry Products HCY assay is substantially equivalent to the previously cleared BIO-RAD® HOMOCYSTEINE by HPLC test (K993107). Devices
-
- Device The VITROS Chemistry Products HCY Reagent is used in conjunction with description the VITROS Chemistry Products Calibrator Kit 27 and VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline) on VITROS 5,1 FS Chemistry Systems to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
The quantitative measurement of homocysteine (HCY) is performed using the VITROS Chemistry Products HCY Reagent in conjunction with the VITROS Chemistry Products Calibrator Kit 27 and on the VITROS 5,1 FS Chemistry Systems. The VITROS Chemistry Products HCY Reagent consists of two dual chambered reagent packs containing three ready-to- use liquid reagents. Disulfide linked homocysteine (oxidized forms) in the sample is reduced by Tris (2-Carboxyethyl) phosphine hydrochloride (TCEP) to form reduced homocysteine. Reduced homocysteine reacts with serine in the presence of cystathionine ß-synthase (CBS) to form L-cystathionine. L-cystathionine is broken down by cystathionine ß-lyase (CBL) to produce homocysteine, pyruvate and ammonia. Pyruvate is reduced to lactate by lactate dehydrogenase (LDH) using NADH as coenzyme. The concentration of HCY is directly proportional to the amount of NADH converted to NAD and is measured spectrophotometrically at 340 nm. Once a calibration has been performed, the HCY concentration in each unknown sample can be determined using the stored calibration curve and the measured absorbance obtained in the assay of the sample.
- Device The VITROS Chemistry Products HCY Reagent is used in conjunction with description the VITROS Chemistry Products Calibrator Kit 27 and VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline) on VITROS 5,1 FS Chemistry Systems to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
The VITROS Chemistry Products Calibrator Kit 27 are prepared from an aqueous solution containing amino acids and inorganic acid. These standards are used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of homocysteine (HCY).
The VITROS Chemistry Products HCY Performance Verifiers I, II and III are prepared from processed human serum to which amino acid and preservative have been added. These are assayed controls used to monitor performance of VITROS HCY Reagents on VITROS 5.1 FS Chemistry Systems.
Continued on next page
2
The VITROS Chemistry Products FS Diluent Pack 2 (Saline/BSA) is a common reagent that is used by multiple assays on the VITROS 5,1 FS Chemistry System. This is a dual chambered package containing two ready-touse liquid diluents. Diluent 1 is prepared from processed water to which inorganic salt has been added. Diluent 2 is prepared from processed water to which bovine serum albumin, inorganic salts and preservatives have been added.
The VITROS 5.1 FS Chemistry System is a clinical chemistry instrument that provides automated use of the VITROS Chemistry Products MicroTip® and MicroSlides® range of products. The VITROS 5,1 FS System was cleared for market by 510(k) premarket notification (K031924).
VITROS Chemistry Products HCY Reagent : For in vitro diagnostic use 6. Device intended only. VITROS Chemistry Products HCY Reagent is used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma. uses Serum and plasma homocysteine levels can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
VITROS Chemistry Products Calibrator Kit 27: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 27 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of homocysteine (HCY).
VITROS Chemistry Products HCY Performance Verifiers I, II & III: For in vitro diagnostic use only. VITROS Chemistry Products HCY Performance Verifiers are assayed controls used to monitor performance of VITROS HCY Reagents on VITROS 5,1 FS Chemistry Systems.
The VITROS Chemistry Products HCY Reagent and VITROS Chemistry 7. Comparison to predicate Products Calibrator Kit 27 are substantially equivalent to the BIO-RAD HOMOCYSTEINE by HPLC test (K993107) (predicate device), which was devices: cleared by the FDA for IVD use.
A least squares linear regression analysis demonstrated the following relationship: y = 0.98 x + 1.0 umol/L, with a correlation coefficient = 0.97 where y = results obtained using the VITROS Chemistry Products HCY assay and x = results obtained with the commercially available system BIO-RAD HOMOCYSTEINE by HPLC test in conventional/SI units (umol/L).
The VITROS Chemistry Products HCY Performance Verifiers I, II & III are substantially equivalent to the VITROS Chemistry Products AAT Performance Verifiers I, II & III (K052819) (predicate device) which was cleared by the FDA for IVD use.
In addition to correlation studies, bench testing was performed to determine assay precision, linearity, specificity, expected values, limit of detection, dilution and specimen matrix of the VITROS HCY assay.
Continued on next page
3
| Table 1 Similarities and differences of the assays performed using the VITROS |
|---|
| HCY assay and the BIO-RAD HOMOCYSTEINE by HPLC test. |
| Device Similarities | |||||
|---|---|---|---|---|---|
| Device | VITROS HCY assay (New device) | ||||
| Characteristic | BIO-RAD HOMOCYSTEINE by HPLC test (Predicate device) | ||||
| Intended Use | For in vitro diagnostic use. Quantitative determination of total | ||||
| Homocysteine in human plasma or serum. | |||||
| Analyte measured | Homocysteine | ||||
| Sample Type | Serum and plasma | ||||
| Measurement Type | Quantitative | ||||
| Device Differences | |||||
| Device | VITROS HCY assay | BIO-RAD HOMOCYSTEINE | |||
| Characteristic | (New device) | by HPLC test | |||
| (Predicate device) | |||||
| Reportable Range | 1.0-50.0 umol/L | 0.5 - 100 umol/L | |||
| Sensitivity | 1.0 umol/L | 0.5 µmol/L | |||
| Calibrator levels | Two levels (0, 27 umol/L) | Single level (15-20 umol/L) | |||
| Calibrator format | Liquid | Lyophilized | |||
| Calibrator matrix | Aqueous solution containing amino | Human Serum | |||
| acids and inorganic acid | |||||
| Instrumentation | Automated clinical chemistry | Isocratic HPLC System | |||
| analyzer | |||||
| Reference Interval | 6.6 - 14.8 umol/L | ||||
| Males: | in vitro diagnostic use. Assayed controls are used to monitor assay performance on VITROS 5,1 FS Chemistry Systems. | ||||
| Matrix | The performance verifiers are prepared from processed human serum with preservatives added. | ||||
| Product Type | Assayed Control | ||||
| Format | Liquid | ||||
| Number of levels | Three | ||||
| Differences | |||||
| Device Characteristic | VITROS HCY Performance Verifiers (New Device) | VITROS AAT Performance Verifiers (Predicate Device) | |||
| Analytes Reported | Homocysteine (HCY) | $\alpha_1$ -Antitrypsin (AAT) |
4
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- Conclusions The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products HCY Reagent, VITROS Chemistry Products Calibrator Kit 27 and the VITROS Chemistry Products HCY 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 a commercially available assay along with patient samples.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is composed of three curved lines that resemble a stylized human figure. The text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 2 1 2006
Mr. Michael M. Byrne Regulatory Associate Ortho-Clinical Creek Dr. 100 Indigo Creek Dr. Rochester, NY 14626
Re: K061588
Trade/Device Name: VITROS Chemistry Products HCY Regent VITROS Chemistry Products Calibrator Kit 27 VITROS Chemistry Products HCY Performance Verifiers I, II, III Regulation Number: 21 CFR8862.1377 Regulation Name: Urinary homocystine (nonquantitative) test system Regulatory Class: Class II Product Code: LPS, JIT, JJX Dated: June 7, 2006 Received: June 8, 2006
Dear Mr. Byrne:
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).
6
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 tollefree 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 Guts
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
7
Indications for Use
Page 1 of 1
| 510(k) Number
| (if known): | k 061588 |
|---|---|
| Device Name: | VITROS Chemistry Products HCY Reagent |
| VITROS Chemistry Products Calibrator Kit 27 | |
| VITROS Chemistry Products HCY Performance Verifiers I, II, | |
| and III | |
| Indications for | |
| Use: | For in vitro diagnostic use only. VITROS Chemistry Products |
| HCY Reagent is used to quantitatively measure total | |
| homocysteine (HCY) concentration in human serum and plasma. | |
| Serum and plasma homocysteine levels can assist in the diagnosis | |
| and treatment of patients suspected of having | |
| hyperhomocysteinemia and homocystinuria. | |
| For in vitro diagnostic use only. VITROS Chemistry Products | |
| Calibrator Kit 27 is used to calibrate VITROS 5,1 FS Chemistry | |
| Systems for the quantitative measurement of homocysteine | |
| (HCY). | |
| For in vitro diagnostic use only. VITROS Chemistry Products | |
| HCY Performance Verifiers are assayed controls used to monitor | |
| performance of VITROS HCY Reagents on VITROS 5,1 FS | |
| Chemistry Systems. | |
| Prescription Use | |
| (Part 21 CFR 801 Subpart D) | X 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 In Vitro Diagnostic Devices (OIVD)
Carol C. Bener
Revision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety