(20 days)
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.
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.
For use in the verification of the calibration established by the Elecsys Vitamin B12 reagent on Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.
(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.
The provided document describes the Elecsys Vitamin B12 Test System, which includes the Elecsys Vitamin B12 Immunoassay, Elecsys Vitamin B12 CalSet II, and Elecsys Vitamin B12 CalCheck. This system is intended for the in vitro quantitative determination of Vitamin B12 in human serum and plasma, used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
The document is a 510(k) Premarket Notification summary, seeking substantial equivalence to previously cleared devices. It primarily focuses on comparing the new device (modified device) to its predicates and detailing the differences and similarities. It does not explicitly state pre-defined acceptance criteria for the modified device's performance, nor does it present a study designed to explicitly prove the device meets such acceptance criteria as a primary outcome.
Instead, the document presents analytical performance data (precision and method comparison) for the modified device and compares it to the predicate device. The goal of this submission is to demonstrate that the changes implemented do not raise new questions of safety and effectiveness, and that the modified device remains substantially equivalent to the predicate.
Given this, I will extract the available performance data and structure the answer to reflect what is present in the document. Since explicit acceptance criteria are not provided for the modified device in the context of a new study to prove "acceptance," I will highlight the reported performance parameters and the context of their presentation (comparison to predicate).
1. Table of Acceptance Criteria and Reported Device Performance
As explicit acceptance criteria for the modified device are not stated in the provided text, the table below presents the reported performance of the modified device alongside that of the predicate device for comparison. The underlying assumption in a 510(k) submission for modifications is that the modified device's performance should be comparable to or better than the predicate, or that any differences do not negatively impact safety and effectiveness.
| Performance Characteristic | Acceptance Criteria (Implicit for 510(k) Substantial Equivalence - generally comparable to predicate) | Elecsys Vitamin B12 (Modified Device) Performance | Elecsys Vitamin B12 (Predicate Device K973702) Performance |
|---|---|---|---|
| Precision (Within-Run) | |||
| Elecsys 2010 | Comparable to Predicate | HS 1: 8.7% (232 pg/mL); HS 2: 4.4% (818 pg/mL); HS 3: 3.0% (1,245 pg/mL) | Human Serum 1: 6.9% (203 pg/mL); Human Serum 2: 4.2% (481 pg/mL); Human Serum 3: 2.7% (1,499 pg/mL) |
| PCA 1: 8.3% (226 pg/mL); PCA 2: 4.0% (610 pg/mL); PCA 3: 3.1% (1,369 pg/mL) | Control 1: 2.8% (1,119 pg/mL); Control 2: 4.3% (471 pg/mL) | ||
| MODULAR ANALYTICS E170 | Comparable to Predicate | HS 1: 1.2% (267 pg/mL); HS 2: 2.9% (887 pg/mL); HS 3: 1.5% (1,308 pg/mL) | Human Serum 1: 2.4% (155 pg/mL); Human Serum 2: 2.8% (359 pg/mL); Human Serum 3: 0.6% (1,162 pg/mL) |
| PCA 1: 1.7% (308 pg/mL); PCA 2: 1.0% (710 pg/mL); PCA 3: 0.8% (1,524 pg/mL) | PreciControl U1: 0.9% (667 pg/mL); PreciControl U2: 4.3% (399 pg/mL) | ||
| Precision (Total) | |||
| Elecsys 2010 | Comparable to Predicate | HS 1: 9.5% (232 pg/mL); HS 2: 5.1% (818 pg/mL); HS 3: 3.7% (1,245 pg/mL) | Human Serum 1: 7.6% (203 pg/mL); Human Serum 2: 4.4% (481 pg/mL); Human Serum 3: 3.2% (1,499 pg/mL) |
| PCA 1: 8.0% (226 pg/mL); PCA 2: 5.2% (610 pg/mL); PCA 3: 3.4% (1,369 pg/mL) | Control 1: 3.2% (1,119 pg/mL); Control 2: 4.6% (471 pg/mL) | ||
| MODULAR ANALYTICS E170 | Comparable to Predicate | HS 1: 8.4% (269 pg/mL); HS 2: 3.3% (853 pg/mL); HS 3: 2.5% (1,261 pg/mL) | Human Serum 1: 6.1% (157 pg/mL); Human Serum 2: 3.6% (349 pg/mL); Human Serum 3: 2.2% (1,128 pg/mL) |
| PCA 1: 7.5% (239 pg/mL); PCA 2: 3.7% (658 pg/mL); PCA 3: 2.4% (1,415 pg/mL) | PreciControl 1: 2.8% (671 pg/mL); PreciControl 2: 4.2% (391 pg/mL) | ||
| Method Comparison | |||
| Predicate vs. Commercially available radiobinding assay | N/A | N/A | N = 345, Passing Bablok: y = -9.2 + 1.06x, r = 0.977, SD(md68) = 45.7; Linear regression: y = 7.4 + 1.02x, r = 0.977, Sy.x = 75.5. Range: 30 - 1,798 pg/mL |
| Modified Device (E170 w/ CalSet II) vs. Predicate (E170 w/ CalSet) | Comparable to Predicate method comparison results (e.g., strong correlation, desirable slope/intercept) | N = 101, 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. Range: 49 - 1,691 pg/mL | N/A |
Note on "Acceptance Criteria": This 510(k) submission is for a modified device demonstrating substantial equivalence. The "acceptance criteria" for such a submission are typically implicit: the modified device's performance data (precision, method comparison, etc.) should demonstrate that the changes do not adversely affect the device's safety and effectiveness compared to the predicate, and that the device performs as intended within clinically acceptable limits. Explicit numerical acceptance criteria are not presented in this summary.
2. Sample Size Used for the Test Set and Data Provenance
-
Precision Study:
- The sample sizes for the human serum samples and controls are not explicitly stated as a single "test set" number for the precision study. Instead, the results are presented for multiple individual samples (HS 1, HS 2, HS 3, PCA 1, PCA 2, PCA 3 for the modified device; Human Serum 1, 2, 3, Control 1, 2 for the predicate) each run multiple times to determine within-run and total precision (CV%). The number of replicates is not specified.
- Data Provenance: Not explicitly stated (e.g., country of origin). It is a laboratory study to assess analytical performance.
- Retrospective/Prospective: Not specified, but analytical performance studies like precision are typically conducted prospectively.
-
Method Comparison Study:
- Modified Device Study Sample Size: N = 101 (comparison of MODULAR ANALYTICS E170 calibrated with Elecsys Vitamin B12 CalSet II vs. E170 calibrated with Elecsys Vitamin B12 CalSet).
- Predicate Device Study Sample Size: N = 345 (comparison of Elecsys Vitamin B12 with a commercially available radiobinding Vitamin B12 assay).
- Data Provenance: Not explicitly stated (e.g., country of origin).
- Retrospective/Prospective: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of submission (for an in vitro diagnostic assay) does not typically involve "experts to establish ground truth" in the same way imaging or clinical decision support AI devices do. The "ground truth" for Vitamin B12 assays is the actual concentration of Vitamin B12 in the samples. For method comparison, an existing, accepted method (predicate device or another commercially available assay) serves as the reference. Therefore, this section is not applicable in the context of this device and study type.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is an analytical performance study for an in vitro diagnostic, not a study involving human interpretation with adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for imaging devices or AI tools that assist human readers in interpretation. The Elecsys Vitamin B12 Test System is an automated in vitro diagnostic assay.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, the studies presented (precision and method comparison) are essentially "standalone" performance evaluations of the assay system itself. The assay is an automated electrochemiluminescence immunoassay (ECLIA) run on Roche Elecsys 2010 and MODULAR ANALYTICS E170 analyzers. Its output is a quantitative measurement of Vitamin B12, not a diagnostic interpretation that requires human-in-the-loop interaction for its primary function.
7. The Type of Ground Truth Used
The "ground truth" for the performance studies shown is:
- Precision: The inherent value of the assayed samples (human serum and controls) determined by repetitive measurements.
- Method Comparison: Values obtained from a previously cleared or commercially available (reference) Vitamin B12 assay. For the modified device, the predicate device calibrated with the original CalSet serves as the reference for method comparison with the modified device using CalSet II.
8. The Sample Size for the Training Set
This information is not provided in the document. This submission describes an in vitro diagnostic device, not a machine learning or AI algorithm that typically has a distinct training set. The "training" for a device like this would involve calibration procedures using specific calibrators (Elecsys Vitamin B12 CalSet II) and master curves, often established during development and manufacturing, rather than a "training set" of patient data in the AI sense.
9. How the Ground Truth for the Training Set was Established
As noted above, this device does not have a "training set" in the context of machine learning. The "ground truth" for instrument calibration is established by using calibrators (Elecsys Vitamin B12 CalSet II) which are "lyophilized product[s] consisting of human serum with added Vitamin B12." These calibrators "are used for calibrating the quantitative Elecsys Vitamin B12 assay." The concentrations of Vitamin B12 in these calibrators are determined during manufacturing and are traceable to a standardization process, which for the modified device is "standardized against the Elecsys Vitamin B12 assay."
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510(k) Summary - Elecsys Vitamin B12 Test System
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence | ||
|---|---|---|---|
| Submittername, address,contact | Roche Diagnostics9115 Hague RdIndianapolis 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 andunassayed). |
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| 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. |
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| Predicatedevice | The Elecsys Vitamin B12 Test System is equivalent to other devices legallymarketed 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 clearedunder K973702.• In 2001 under K961481/A003, the MODULAR ANALYTICS E170analyzer was acknowledged by FDA. | |
| For the Vitamin B12 CalCheck:• The original Elecsys Vitamin B12 CalCheck was cleared underK974383. |
·
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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 vitroquantitative determination of vitaminB12 in human serum and plasma. Theelectrochemiluminescenceimmunoassay “ECLIA” is intendedfor use on the Roche Elecsys1010/2010 and MODULARANALYTICS E170 (Elecsys module)immunoassay analyzers. | Binding assay for the in vitroquantitative determination of vitaminB12 in human serum and plasma. Theelectrochemiluminescenceimmunoassay “ECLIA” is intendedfor use on the Roche Elecsys 2010 andMODULAR ANALYTICS E170(Elecsys module) immunoassayanalyzers. |
| Assay Protocol | Competitive assay | Same |
| Detection Protocol | Electrochemiluminescenceimmunoassay | Same |
| Measuring range | 30 -2,000 pg/mL | Same |
| Analyticalsensitivity(lower detectionlimit) | 30 pg/mL | Same |
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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 forcalibrating the quantitative Elecsys B12assay on the Elecsys 2010immunoassay system. | Elecsys Vitamin B12 CalSet II is usedfor calibrating the quantitative ElecsysVitamin B12 assay on the Elecsys 2010and MODULAR ANALYTICS E170immunoassay analyzers. | ||
| Levels | Two | Same |
Continued on next page
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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 thecalibration established by the ElecsysVitamin B12 reagent and CalSet on theElecsys 2010 immunoassay analyzer. | For use in the verification of thecalibration established by the ElecsysVitamin B12 reagent on Elecsys 2010and MODULAR ANALYTICS E170immunoassay analyzers. | ||
| Levels | Three | Same |
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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 | ||
| Qualitycontrol | 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) | |
| Specimencollectionandpreparation | No additional statement was provided. | A note was added to this section:Note: Samples with extremely hightotal protein concentrations (e.g.patients suffering from Waldenstrom'smacroglulinemia) are not suitable foruse in this assay, since they may leadto the formation of protein gel in theassay cup. Processing protein gel maycause a run abort. The critical proteinis dependent upon the individualsample composition. The formation ofprotein gel was seen in samples(spiked with human IgG or humanserum albumin) having a total proteinconcentration of > 160 g/L. |
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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 |
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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 | ||
| Methodcomparison | Comparison of the Elecsys Vitamin B12(y) with a commercially availableradiobinding Vitamin B12 assay (x): | Comparison of the Elecsys Vitamin B12assay MODULAR ANALYTICS E170calibrated with the Elecsys VitaminB12 CalSet(x) versus the MODULARANALYTICS E170 calibrated with theElecsys Vitamin B12 CalSet II (y): |
| N = 345 | N = 101 | |
| Passing Bablok:$y = -9.2 + 1.06x$r = 0.977SD(md68) = 45.7 | Passing Bablok:$y = 0.982x - 0.018$r = 0.977SD(md68) = 8.05 | |
| Linear regression:$y = 7.4 +1.02x$r = 0.977Sy.x = 75.5 | Linear regression:$y = 0.968x + 5.77$r = 0.999Sy.x = 9.63 | |
| Sample concentrations range:30 - 1,798 pg/mL | Sample concentration range:49 - 1,691 pg/mL |
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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 beencalibrated against a commerciallyavailable radiobinding Vitamin B12assay. | This method has been standardizedagainst the Elecsys Vitamin B12 assay. |
| Stability | Unopened at 2 - 8°C:Up to the stated expiration dateAfter opening:12 weeks at 2 - 8°COn E170/Elecsys 2010:8 weeks | Unopened at 2 - 8°C:Up to the stated expiration dateAfter opening at 2 - 8°C:12 weeksOn Elecsys 2010:5 weeksOn MODULAR ANALYTICS E170:5 weeks |
| Expected values | Normal rangeUnited States:243 – 894 pg/mLEurope:197 - 866 pg/mL | Normal range:United States:211 – 946 pg/mLEurope:191 – 663 pg/mL |
| Calibrationverification | Not necessary. The analyzer'ssoftware automatically checks thevalidity of the curve and drawsattention to any deviations. | Section deleted. |
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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 2010immunoassay analyzer. | To be used on Elecsys 2010 and theMODULAR ANALYTICS E170immunoassay analyzers. |
| Matrix | Human serum albumin with addedVitamin B12 | Human serum with added Vitamin B12 |
| Storage form | Liquid | Lyophilized |
| Filling volume | 1.5 mL | 1.0 mL |
| Concentrationranges | Cal 1: approximately 100 pg/mLCal 2: approximately 1,500 pg/mL | Cal 1: approximately 250 pg/mLCal 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 daysAt -20°C: 3 months (freeze onlyonce) | |
| 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 standardizedagainst the Elecsys Vitamin B12 assay(Cat. No. 11820753). |
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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 2010immunoassay analyzer. | To be used on the Elecsys 2010 andthe MODULAR ANALYTICS E170immunoassay analyzer. |
| Matrix | Buffer matrix with added humanserum albumin. | Human serum matrix |
| Storage | Liquid | Lyophilized |
| Fill Volume | 1.9 mL | 1.0 mL |
| Targetconcentration | Level 1: Approximately 150 pg/mLLevel 2: Approximately 875 pg/mLLevel 3: Approximately 1,600 pg/mL | Level 1: ≤ 300 pg/mLLevel 2: SameLevel 3: Same |
| Traceability | None listed in the package insert. | This method has been standardizedagainst the Elecsys Vitamin B12 assay. |
| Stability | Store unopened at 2 - 8°C:Up to the printed expiration date onthe bottle labels. | Store unopened at 2 - 8°C:Up to the printed expiration date onthe bottles labels. |
| Stability opened:5 hours at 20-25°C | Stability reconstituted:4 hours at 20-25°C |
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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).
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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
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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
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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
§ 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.