(20 days)
K961481/A003
No
The description details a standard immunoassay using electrochemiluminescence and a competitive binding principle. The results are determined via a calibration curve, which is a traditional method and does not indicate the use of AI/ML. There are no mentions of AI, ML, or related terms in the provided text.
No
This device is an in vitro diagnostic test system that measures vitamin B12 levels to aid in diagnosis, not a device that provides therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurements obtained by this device are "used in the diagnosis and treatment of anemias of gastrointestinal malabsorption." This directly indicates its role in diagnosis.
No
The device description explicitly details physical components (reagents, calibrators, controls) and mentions use on specific hardware analyzers (Roche Elecsys 2010 and MODULAR ANALYTICS E170). This indicates it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "Binding assay for the in vitro quantitative determination of vitamin B12 in human serum and plasma." The term "in vitro" is a key indicator of an IVD. It also mentions the use of the device in the "diagnosis and treatment of anemias of gastrointestinal malabsorption," which is a diagnostic purpose.
- Device Description: The description details how the assay works by analyzing components of the sample (serum and plasma) outside of the body.
- Regulatory Context: The mention of predicate devices with K numbers (K973702, K961481/A003, K974383) strongly suggests that this device has gone through the regulatory process for medical devices, specifically IVDs, in the United States (likely with the FDA).
Therefore, based on the provided information, this device clearly fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
(1) The Vitamin B12 assay is a Binding assay for the in vitro quantitative determination of vitamin B12 in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers. A Vitamin B12 test system is a device intended to measure Vitamin B12 in serum, plasma. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
(2) Elecsys Vitamin B12 CalSet II is used for calibrating the quantitative Elecsys Vitamin B12 assay on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.
(3) For use in the verification of the calibration established by the Elecsys Vitamin B12 reagent on Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
CDD, JIT, JJX
Device Description
(1) The Elecsys Vitamin B12 Assay employs a competitive test principle using intrinsic factor specific for Vitamin B12. Vitamin B12 in the sample competes with the added Vitamin B12 labeled with biotin for the binding sites on the ruthenium-labeled intrinsic factor complex. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.
(2) The Elecsys Vitamin B12 CalSet II is a lyophilized product consisting of human serum with added Vitamin B12 in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
(3) The Elecsys Vitamin B12 CalCheck is a lyophilized product consisting of human serum with added Vitamin B12. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
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
Prescription Use
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)
Precision (Elecsys 2010):
- Within-Run:
- Human Serum 1: 8.7% at 232 pg/mL
- Human Serum 2: 4.4% at 818 pg/mL
- Human Serum 3: 3.0% at 1,245 pg/mL
- PCA 1: 8.3% at 226 pg/mL
- PCA 2: 4.0% at 610 pg/mL
- PCA 3: 3.1% at 1,369 pg/mL
- Total:
- Human Serum 1: 9.5% at 232 pg/mL
- Human Serum 2: 5.1% at 818 pg/mL
- Human Serum 3: 3.7% at 1,245 pg/mL
- PCA 1: 8.0% at 226 pg/mL
- PCA 2: 5.2% at 610 pg/mL
- PCA 3: 3.4% at 1,369 pg/mL
Precision (MODULAR ANALYTICS E170):
- Within-Run:
- Human Serum 1: 1.2% at 267 pg/mL
- Human Serum 2: 2.9% at 887 pg/mL
- Human Serum 3: 1.5% at 1,308 pg/mL
- PCA 1: 1.7% at 308 pg/mL
- PCA 2: 1.0% at 710 pg/mL
- PCA 3: 0.8% at 1,524 pg/mL
- Total:
- Human Serum 1: 8.4% at 269 pg/mL
- Human Serum 2: 3.3% at 853 pg/mL
- Human Serum 3: 2.5% at 1,261 pg/mL
- PCA 1: 7.5% at 239 pg/mL
- PCA 2: 3.7% at 658 pg/mL
- PCA 3: 2.4% at 1,415 pg/mL
Method Comparison:
- Study Type: Comparison of Elecsys Vitamin B12 assay MODULAR ANALYTICS E170 calibrated with Elecsys Vitamin B12 CalSet (x) versus MODULAR ANALYTICS E170 calibrated with Elecsys Vitamin B12 CalSet II (y).
- Sample Size: N = 101
- Key Results:
- Passing Bablok: $y = 0.982x - 0.018$, r = 0.977, SD(md68) = 8.05
- Linear regression: $y = 0.968x + 5.77$, r = 0.999, Sy.x = 9.63
- Sample concentration range: 49 - 1,691 pg/mL
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.
K961481/A003
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
§ 862.1810 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.
0
510(k) Summary - Elecsys Vitamin B12 Test System
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence | | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--|
| Submitter
name, address,
contact | Roche Diagnostics
9115 Hague Rd
Indianapolis IN 46250
(317) 521-3532 | | |
| | Contact person: Randy Johnson | | |
| | Date prepared: March 20, 2006 | | |
| Device name | Proprietary name: | (1) Elecsys Vitamin B12 Immunoassay
(2) Elecsys Vitamin B12 CalSet II
(3) Elecsys Vitamin B12 CalCheck | |
| | Common name: | (1) Vitamin B12 Assay
(2) Vitamin B12 CalSet
(3) Vitamin B12 CalCheck | |
| | Classification name: | (1) Radioassay, Vitamin B12
(2) Calibrator, Secondary
(3) Single (specified) analyte controls (assayed and
unassayed). | |
1
| Device description | (1) The Elecsys Vitamin B12 Assay employs a competitive test principle using intrinsic factor specific for Vitamin B12. Vitamin B12 in the sample competes with the added Vitamin B12 labeled with biotin for the binding sites on the ruthenium-labeled intrinsic factor complex. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode. |
|---|---|
| (2) The Elecsys Vitamin B12 CalSet II is a lyophilized product consisting of human serum with added Vitamin B12 in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. | |
| (3) The Elecsys Vitamin B12 CalCheck is a lyophilized product consisting of human serum with added Vitamin B12. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. | |
| Intended use | (1) The Vitamin B12 assay is a Binding assay for the in vitro quantitative determination of vitamin B12 in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers. |
| (2) Elecsys Vitamin B12 CalSet II is used for calibrating the quantitative Elecsys Vitamin B12 assay on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers. | |
| (3) For use in the verification of the calibration established by the Elecsys Vitamin B12 reagent on Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers. |
2
| Predicate
device | The Elecsys Vitamin B12 Test System is equivalent to other devices legally
marketed in the United States. We claim equivalence for the following items: |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | For the Vitamin B12 assay and the Vitamin B12 CalSet II:
• The original Elecsys Vitamin B12 on the Elecsys 2010 was cleared
under K973702.
• In 2001 under K961481/A003, the MODULAR ANALYTICS E170
analyzer was acknowledged by FDA. |
| | For the Vitamin B12 CalCheck:
• The original Elecsys Vitamin B12 CalCheck was cleared under
K974383. |
·
3
Device comparison (Reagents)
The table below compares the Elecsys Vitamin B12 (K973702) and the Elecsys Vitamin B12 (modified device).
Substantial equivalence - similarities
| Topic | Elecsys Vitamin B12
(K973702) | Elecsys Vitamin B12
(Modified Device) |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | REAGENTS | |
| Intended use | Binding assay for the in vitro
quantitative determination of vitamin
B12 in human serum and plasma. The
electrochemiluminescence
immunoassay “ECLIA” is intended
for use on the Roche Elecsys
1010/2010 and MODULAR
ANALYTICS E170 (Elecsys module)
immunoassay analyzers. | Binding assay for the in vitro
quantitative determination of vitamin
B12 in human serum and plasma. The
electrochemiluminescence
immunoassay “ECLIA” is intended
for use on the Roche Elecsys 2010 and
MODULAR ANALYTICS E170
(Elecsys module) immunoassay
analyzers. |
| Assay Protocol | Competitive assay | Same |
| Detection Protocol | Electrochemiluminescence
immunoassay | Same |
| Measuring range | 30 -2,000 pg/mL | Same |
| Analytical
sensitivity
(lower detection
limit) | 30 pg/mL | Same |
4
Device comparison (Calibrators) The table below compares the Elecsys Vitamin B12 CalSet (K973702) and the Elecsys Vitamin B12 CalSet II (modified device).
Substantial equivalence - similarities
| Topic | Elecsys Vitamin B12 CalSet
(K973702) | Elecsys Vitamin B12 CalSet II
(Modified Device) | | |
|--------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| CALIBRATORS | | | | |
| Intended use | Elecsys B12 CalSet is used for
calibrating the quantitative Elecsys B12
assay on the Elecsys 2010
immunoassay system. | Elecsys Vitamin B12 CalSet II is used
for calibrating the quantitative Elecsys
Vitamin B12 assay on the Elecsys 2010
and MODULAR ANALYTICS E170
immunoassay analyzers. | | |
| Levels | Two | Same | | |
Continued on next page
and the same of the state of the state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the sta
5
Device The table below compares the Elecsys Vitamin B12 CalCheck (K974383) and comparison the Elecsys Vitamin B12 CalCheck (modified device). (CalCheck)
and the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the comments of the contribution of the contribution o
Substantial equivalence - similarities
| Topic | Elecsys Vitamin B12 CalCheck
(K974383) | Elecsys Vitamin B12 CalCheck
(Modified Device) | | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| CALIBRATION VERIFICATION | | | | |
| Intended use | For use in the verification of the
calibration established by the Elecsys
Vitamin B12 reagent and CalSet on the
Elecsys 2010 immunoassay analyzer. | For use in the verification of the
calibration established by the Elecsys
Vitamin B12 reagent on Elecsys 2010
and MODULAR ANALYTICS E170
immunoassay analyzers. | | |
| Levels | Three | Same | | |
6
Device comparison (Reagents)
The table below compares the differences between the Elecsys Vitamin B12 (K973702) and the Elecsys Vitamin B12 (modified device).
Substantial equivalence - differences
| Topic | Elecsys Vitamin B12
(K973702) | Elecsys Vitamin B12
(Modified Device) |
|----------------------------------------------|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| REAGENTS | | |
| Quality
control | Elecsys PreciControl Universal | Elecsys PreciControl Anemia 1, 2 and 3 |
| Formulation
(PT2) | Composition of PT2: | Composition of PT2: |
| | 36 g/L NaOH (0.9 M) | 40 g/L NaOH (1.0M) |
| Specimen
collection
and
preparation | No additional statement was provided. | A note was added to this section:
Note: Samples with extremely high
total protein concentrations (e.g.
patients suffering from Waldenstrom's
macroglulinemia) are not suitable for
use in this assay, since they may lead
to the formation of protein gel in the
assay cup. Processing protein gel may
cause a run abort. The critical protein
is dependent upon the individual
sample composition. The formation of
protein gel was seen in samples
(spiked with human IgG or human
serum albumin) having a total protein
concentration of > 160 g/L. |
7
Device comparison (Reagents),
The table below compares the differences between the Elecsys Vitamin B12 (K973702) and the Elecsys Vitamin B12 (modified device).
continued
Substantial equivalence – differences
| Topic | Elecsys Vitamin B12
(K973702) | | Elecsys Vitamin B12
(Modified Device) | |
|-----------|----------------------------------|-------------|------------------------------------------|-------------|
| | REAGENTS | | | |
| Precision | Elecsys 2010 | | Elecsys 2010 | |
| | Within-Run: | | Within-Run: | |
| | Human Serum 1: 6.9% | 203 pg/mL | HS 1: 8.7% | 232 pg/mL |
| | Human Serum 2: 4.2% | 481 pg/mL | HS 2: 4.4% | 818 pg/mL |
| | Human Serum 3: 2.7% | 1,499 pg/mL | HS 3: 3.0% | 1,245 pg/mL |
| | Control 1: 2.8% | 1,119 pg/mL | PCA 1: 8.3% | 226 pg/mL |
| | Control 2: 4.3% | 471 pg/mL | PCA 2: 4.0% | 610 pg/mL |
| | | | PCA 3: 3.1% | 1,369 pg/mL |
| | Total: | | Total: | |
| | Human Serum 1: 7.6% | 203 pg/mL | HS 1: 9.5% | 232 pg/mL |
| | Human Serum 2: 4.4% | 481 pg/mL | HS 2: 5.1% | 818 pg/mL |
| | Human Serum 3: 3.2% | 1,499 pg/mL | HS 3: 3.7% | 1,245 pg/mL |
| | Control 1: 3.2% | 1,119 pg/mL | PCA 1: 8.0% | 226 pg/mL |
| | Control 2: 4.6% | 471 pg/mL | PCA 2: 5.2% | 610 pg/mL |
| | | | PCA 3: 3.4% | 1,369 pg/mL |
| | MODULAR ANALYTICS E170 | | MODULAR ANALYTICS E170 | |
| | Within-Run: | | Within-Run: | |
| | Human Serum 1: 2.4% | 155 pg/mL | HS 1: 1.2% | 267 pg/mL |
| | Human Serum 2: 2.8% | 359 pg/mL | HS 2: 2.9% | 887 pg/mL |
| | Human Serum 3: 0.6% | 1,162 pg/mL | HS 3: 1.5% | 1,308 pg/mL |
| | PreciControl U1: 0.9% | 667 pg/mL | PCA 1: 1.7% | 308 pg/mL |
| | PreciControl U2: 4.3% | 399 pg/mL | PCA 2: 1.0% | 710 pg/mL |
| | | | PCA 3: 0.8% | 1,524 pg/mL |
| | Total: | | Total: | |
| | Human Serum 1: 6.1% | 157 pg/mL | HS 1: 8.4% | 269 pg/mL |
| | Human Serum 2: 3.6% | 349 pg/mL | HS 2: 3.3% | 853 pg/mL |
| | Human Serum 3: 2.2% | 1,128 pg/mL | HS 3: 2.5% | 1,261 pg/mL |
| | PreciControl 1: 2.8% | 671 pg/mL | PCA 1: 7.5% | 239 pg/mL |
| | PreciControl 2: 4.2% | 391 pg/mL | PCA 2: 3.7% | 658 pg/mL |
| | | | PCA 3: 2.4% | 1,415 pg/mL |
8
Device comparison (Reagents), continued
The table below compares the differences between the Elecsys Vitamin B12 (K973702) and the Elecsys Vitamin B12 (modified device).
Substantial equivalence - differences
| Topic | Elecsys Vitamin B12
(K973702) | Elecsys Vitamin B12
(Modified Device) |
|----------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | REAGENTS | |
| Method
comparison | Comparison of the Elecsys Vitamin B12
(y) with a commercially available
radiobinding Vitamin B12 assay (x): | Comparison of the Elecsys Vitamin B12
assay MODULAR ANALYTICS E170
calibrated with the Elecsys Vitamin
B12 CalSet(x) versus the MODULAR
ANALYTICS E170 calibrated with the
Elecsys Vitamin B12 CalSet II (y): |
| | N = 345 | N = 101 |
| | Passing Bablok:
$y = -9.2 + 1.06x$
r = 0.977
SD(md68) = 45.7 | Passing Bablok:
$y = 0.982x - 0.018$
r = 0.977
SD(md68) = 8.05 |
| | Linear regression:
$y = 7.4 +1.02x$
r = 0.977
Sy.x = 75.5 | Linear regression:
$y = 0.968x + 5.77$
r = 0.999
Sy.x = 9.63 |
| | Sample concentrations range:
30 - 1,798 pg/mL | Sample concentration range:
49 - 1,691 pg/mL |
9
The table below compares the differences between the Elecsys Vitamin B12 Device comparison (K973702) and the Elecsys Vitamin B12 (modified device). (Reagents), continued
Substantial equivalence - differences
| Topic | Elecsys Vitamin B12
(K973702) | Elecsys Vitamin B12
(Modified Device) |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| REAGENTS | | |
| Traceability | Elecsys Vitamin B12 has been
calibrated against a commercially
available radiobinding Vitamin B12
assay. | This method has been standardized
against the Elecsys Vitamin B12 assay. |
| Stability | Unopened at 2 - 8°C:
Up to the stated expiration date
After opening:
12 weeks at 2 - 8°C
On E170/Elecsys 2010:
8 weeks | Unopened at 2 - 8°C:
Up to the stated expiration date
After opening at 2 - 8°C:
12 weeks
On Elecsys 2010:
5 weeks
On MODULAR ANALYTICS E170:
5 weeks |
| Expected values | Normal range
United States:
243 – 894 pg/mL
Europe:
197 - 866 pg/mL | Normal range:
United States:
211 – 946 pg/mL
Europe:
191 – 663 pg/mL |
| Calibration
verification | Not necessary. The analyzer's
software automatically checks the
validity of the curve and draws
attention to any deviations. | Section deleted. |
10
Device The table below compares the differences between the Elecsys Vitamin B12 comparison CalSet (K973702) and the Elecsys Vitamin B12 CalSet II (modified device). (Calibrator)
Substantial equivalence - differences
| Topic | Elecsys Vitamin B12 CalSet
(K973702) | Elecsys Vitamin B12 CalSet II
(Modified Device) |
|-------------------------|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| | CALIBRATOR | |
| Platform | To be used on the Elecsys 2010
immunoassay analyzer. | To be used on Elecsys 2010 and the
MODULAR ANALYTICS E170
immunoassay analyzers. |
| Matrix | Human serum albumin with added
Vitamin B12 | Human serum with added Vitamin B12 |
| Storage form | Liquid | Lyophilized |
| Filling volume | 1.5 mL | 1.0 mL |
| Concentration
ranges | Cal 1: approximately 100 pg/mL
Cal 2: approximately 1,500 pg/mL | Cal 1: approximately 250 pg/mL
Cal 2: approximately 1,500 pg/mL |
| Stability | Unopened at 2 - 8°C:
Up to the stated expiration date | Unopened at 2 - 8°C:
Up to the stated expiration date |
| | After opening:
12 weeks at 2 - 8°C | After reconstitution:
At 2 - 8°C: 3 days
At -20°C: 3 months (freeze only
once) |
| | On the analyzer:
Up to 5 hours in total | On the analyzer at 20 - 25°C:
Use only once. |
| Traceability | None listed in the package insert. | The Elecsys Vitamin B12 assay (Cat.
No. 04745736) has been standardized
against the Elecsys Vitamin B12 assay
(Cat. No. 11820753). |
11
Device The table below compares the differences between the Elecsys Vitamin B12 comparison CalCheck (K974383) and the Elecsys Vitamin B12 CalCheck (modified (Calibration device). verification)
Substantial equivalence - differences
| Topic | Elecsys Vitamin B12 CalCheck
(K974383) | Elecsys Vitamin B12 CalCheck
(Modified Device) |
|--------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| CALIBRATION VERIFICATION | | |
| Platform | To be used on the Elecsys 2010
immunoassay analyzer. | To be used on the Elecsys 2010 and
the MODULAR ANALYTICS E170
immunoassay analyzer. |
| Matrix | Buffer matrix with added human
serum albumin. | Human serum matrix |
| Storage | Liquid | Lyophilized |
| Fill Volume | 1.9 mL | 1.0 mL |
| Target
concentration | Level 1: Approximately 150 pg/mL
Level 2: Approximately 875 pg/mL
Level 3: Approximately 1,600 pg/mL | Level 1: ≤ 300 pg/mL
Level 2: Same
Level 3: Same |
| Traceability | None listed in the package insert. | This method has been standardized
against the Elecsys Vitamin B12 assay. |
| Stability | Store unopened at 2 - 8°C:
Up to the printed expiration date on
the bottle labels. | Store unopened at 2 - 8°C:
Up to the printed expiration date on
the bottles labels. |
| | Stability opened:
5 hours at 20-25°C | Stability reconstituted:
4 hours at 20-25°C |
12
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 0 2006
Mr. Randy J. Johnson M.T. (ASCP), Regulatory Affairs Consultant Roche Diagnostics Corp. 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457
Re: K060755
Trade/Device Name: Elecsys Vitamin B12 Immunoassay, Calset II and Cacheck Regulation Number: 21 CFR§862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: Class II Product Code: CDD, JIT, JJX Dated: March 20, 2006 Received: March 21, 2006
Dear Mr. Johnson:
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).
13
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 yours,
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
14
Indications for Use
510(k) Number (if known): _K060755
Device Name: Elecsys Vitamin B12 Assay
Indications For Use:
Binding assay for the in vitro quantitative determination of vitamin B12 in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
A Vitamin B12 test system is a device intended to measure Vitamin B12 in serum, plasma. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
Prescription Use XXXX (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 In Vitro Diagnostic Devices (OIVD)
CAC
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K060755
15
Indications for Use
510(k) Number (if known): K060755
Device Name: Elecsys Vitamin B12 CalSet II
Indications For Use:
Elecsys Vitamin B12 CalSet II is used for calibrating the quantitative Elecsys Vitamin B12 assay on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.
Prescription Use XXXX (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 In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vit · Diagnostic Device Evaluation and Safety
060755
16
Indications for Use
510(k) Number (if known): _K060755
Device Name: Elecsys Vitamin B12 CalCheck
Indications For Use:
ﺮ ﺍﻟﻤﺮﺍﺟﻊ
For use in the verification of the calibration established by the Elecsys Vitamin B12 reagent on Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.
Prescription Use XXXX (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 In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Viro Diagnostic Device . Evaluation and Safety
K06075T