(121 days)
The Elecsys PTH Immunoassay is for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma as an aid in the differential diagnosis of hypercalcemia and hypocalcemia and can be used intraoperatively. The Elecsys PTH STAT Immunoassay is for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia and can be used intraoperatively. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys PTH and Elecsys PTH STAT Assays are two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.
The provided text details a 510(k) summary for the "Elecsys PTH Immunoassay" and "Elecsys PTH STAT Immunoassay" devices, seeking to demonstrate substantial equivalence to a predicate device (Elecsys PTH Assay, K992680). The information mainly focuses on comparing the features and performance of the modified devices against the predicate, particularly in terms of assay duration, platforms, and analytical performance characteristics like precision.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a go/no-go format for external validation. Instead, it presents a comparison of the modified devices' performance characteristics against those of the predicate device (Elecsys PTH Assay, K992680), implying that performance similar to or improved over the predicate is acceptable. The detailed aspects compared are:
| Feature | Predicate Device (Elecsys PTH Assay, K992680) | Modified Device (Elecsys PTH 18 min appl.) | Modified Device (Elecsys PTH STAT 9 min appl.) |
|---|---|---|---|
| Intended Use/Indications | In vitro quantitative determination of intact PTH in human serum and plasma for differential diagnosis of hypercalcemia and hypocalcemia. | Same, plus "can be used intraoperatively." | Same, plus "can be used intraoperatively." |
| Assay Protocol | Sandwich assay | Same | Same |
| Detection Protocol | Electrochemiluminescent Immunoassay | Same | Same |
| Platform(s) | Elecsys 1010, Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, cobas e 601. | Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, cobas e 601. | Elecsys 1010, Elecsys 2010, cobas e 411. |
| Total Assay Duration | Elecsys 1010: 9 min; Others: 18 min | 18 minute | 9 minute |
| Sample Type | Human serum and plasma treated with K3-EDTA. | Same | Same |
| Calibrator | Elecsys PTH CalSet | Same | Elecsys PTH STAT CalSet |
| Reagent Stability | Unopened: 2-8°C (up to expiration date); Opened: 2-8°C (8-12 weeks depending on platform, with 1010 having specific ambient temp/duration limits) | Unopened: 2-8°C (up to expiration date); Opened: 2-8°C (8-12 weeks depending on platform) | Unopened: 2-8°C (up to expiration date); Opened: 2-8°C (8-12 weeks depending on platform, with 1010 having specific ambient temp/duration limits) |
| Measuring Range | 1.20 – 5,000 pg/mL | Same | Same |
| Analytical sensitivity (LDL) | 1.20 pg/mL (0.127 pmol/L) | Same | Same |
| Analytical Specificity | No cross-reactivity with Osteocalcin, PTH 1-37, bone-specific alkaline phosphatase, β-Crosslaps. | Same (reworded for clarity) | Same (reworded for clarity) |
| Traceability/Standardization | Standardized against a commercial PTH test (RIA). | Same (slight wording change) | Standardized against Elecsys PTH, which was standardized against a commercial PTH test (RIA). |
| Hook Effect | No high dose hook effect up to 17,000 pg/mL. | Same | Same |
| Calibration Interval | Once per reagent lot (fresh reagent). Renewed calibration after 1 month/7 days depending on platform. | Same | Same |
| Precision (Within-run CV) | Elecsys 1010/2010: 4.0-5.8% (30-271 pg/mL); E170: 1.1-2.8% (25-1215 pg/mL) | Elecsys 2010/cobas e411: 1.5-4.1% (20.2-676 pg/mL); E170/cobas e601: 0.6-2.8% (21.9-1092 pg/mL) | Elecsys 1010: 3.4-5.8% (30-702 pg/mL); Elecsys 2010/cobas e411: 1.6-2.1% (52.6-980 pg/mL) |
| Precision (Total CV) | Elecsys 1010/2010: 4.3-7.1% (30-702 pg/mL); E170: 1.6-3.4% (26.4-1222 pg/mL) | Elecsys 2010/cobas e411: 2.6-6.5% (20.2-676 pg/mL); E170/cobas e601: 1.6-3.4% (23.2-1098 pg/mL) | Elecsys 1010: 4.3-7.1% (30-702 pg/mL); Elecsys 2010/cobas e411: 1.9-3.8% (52.6-980 pg/mL) |
| Limitations (Hemolysis) | Unaffected by Hb < 0.932 mmol/L (<1.5 g/dL). | Affected by Hb ≥ 0.10 g/dL (3-5 pg/mL reduction for PTH < 50 pg/mL; <10% for PTH ≥ 50 pg/mL). | Affected by Hb ≥ 0.25 g/dL. |
| Limitations (Other) | Unaffected by Icterus, Lipemia, Biotin (specific levels). No RF interference up to 1,500 IU/mL. No interference from 16 common pharmaceuticals. Interference possible with monoclonal mouse antibodies/ruthenium/streptavidin antibodies. | Same for Icterus, Lipemia, Biotin, RF, common pharmaceuticals, monoclonal mouse antibodies/ruthenium/streptavidin antibodies. | Same for Icterus, Lipemia, Biotin, RF, common pharmaceuticals, monoclonal mouse antibodies/ruthenium/streptavidin antibodies. |
Study Details:
The provided text is a 510(k) summary for in vitro diagnostic (IVD) devices. IVD submissions of this nature primarily rely on analytical performance studies to demonstrate substantial equivalence to a predicate device, rather than the types of clinical or comparative effectiveness studies often associated with diagnostic imaging AI.
2. Sample Size Used for the Test Set and Data Provenance:
The document provides specific data points for precision studies, which serve as the "test set" for this type of analytical device. However, the exact total sample size (number of individual patient samples) for these precision studies is not explicitly stated. Instead, it reports Coefficient of Variation (CV) values at different mean PTH concentrations, which are typically derived from replicate measurements of control materials or pooled patient samples over several runs.
- Elecsys PTH (18 min appl.) Precision Study Data:
- Within-run CV: 2.7% @ 26.7 pg/mL, 1.6% @ 52.5 pg/mL, 1.5% @ 261 pg/mL, 4.1% @ 20.2 pg/mL, 2.2% @ 58.0 pg/mL, 1.9% @ 676 pg/mL (Elecsys 2010/cobas e411)
- Total CV: 6.5% @ 26.7 pg/mL, 3.9% @ 52.5 pg/mL, 3.0% @ 261 pg/mL, 6.2% @ 20.2 pg/mL, 4.1% @ 58.0 pg/mL, 2.6% @ 676 pg/mL (Elecsys 2010/cobas e411)
- Within-run CV: 2.0% @ 21.9 pg/mL, 1.2% @ 35.0 pg/mL, 1.1% @ 123 pg/mL, 2.2% @ 72.7 pg/mL, 2.8% @ 236 pg/mL, 0.6% @ 1,092 pg/mL (E170/cobas e601)
- Total CV: 3.4% @ 23.2 pg/mL, 2.5% @ 80.9 pg/mL, 2.8% @ 240 pg/mL, 1.7% @ 73.0 pg/mL, 1.6% @ 238 pg/mL, 1.6% @ 1,098 pg/mL (E170/cobas e601)
- Elecsys PTH STAT (9 min appl.) Precision Study Data:
- Within-run CV: 5.4% @ 30.0 pg/mL, 4.0% @ 62.2 pg/mL, 4.0% @ 271 pg/mL, 5.8% @ 44.3 pg/mL, 3.4% @ 161 pg/mL, 3.9% @ 702 pg/mL (Elecsys 1010)
- Total CV: 5.9% @ 30.0 pg/mL, 4.3% @ 62.2 pg/mL, 4.3% @ 271 pg/mL, 7.1% @ 44.3 pg/mL, 5.0% @ 161 pg/mL, 5.4% @ 702 pg/mL (Elecsys 1010)
- Within-run CV: 2.1% @ 53.4 pg/mL, 1.7% @ 215 pg/mL, 1.7% @ 980 pg/mL, 1.6% @ 52.6 pg/mL, 2.0% @ 182 pg/mL, 1.8% @ 744 pg/mL (Elecsys 2010/cobas e411)
- Total CV: 3.8% @ 53.4 pg/mL, 2.8% @ 215 pg/mL, 2.5% @ 980 pg/mL, 1.9% @ 52.6 pg/mL, 2.5% @ 182 pg/mL, 2.2% @ 744 pg/mL (Elecsys 2010/cobas e411)
The data provenance (country of origin, retrospective/prospective) is not specified in the provided text. For IVD devices, such studies are typically performed in a controlled laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This is not applicable to the type of device and study described. For an immunoassay, the "ground truth" for analytical performance studies is typically established by physical measurements and reference materials with known concentrations, or by comparison to a well-established reference method, not by expert consensus or interpretations in the way it applies to diagnostic imaging.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the "test set" here refers to analytical performance data, not a set of cases requiring adjudication by human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is an IVD device for quantitative determination in serum/plasma, not a diagnostic imaging AI system that would involve human readers or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone analytical instrument (immunoassay) that provides quantitative results. Its performance, as detailed in the precision data, is "algorithm only" in the sense that it mechanically measures and processes a sample to produce a numerical result without human interpretation of raw data for diagnosis. The output (PTH concentration) is then used by a clinician for diagnosis, but the measurement itself is automated.
7. The Type of Ground Truth Used:
For this type of IVD, the "ground truth" for analytical performance tests would be established through a combination of:
- Reference Materials/Standards: Samples with known, certified concentrations of PTH.
- Comparison to a Validated Reference Method: The document states the methods were "standardized against a commercial PTH test (RIA)," implying that the RIA assay serves as a reference for establishing accuracy and traceability.
8. The Sample Size for the Training Set:
This concept of a "training set" is not directly applicable in the context of an immunoassay like the Elecsys PTH. These devices are based on established biochemical principles (sandwich immunoassay, electrochemiluminescence) and calibrated using reference materials. There isn't a "machine learning algorithm" in the typical sense that requires a large dataset for training. The instrument's internal "algorithm" refers to its pre-programmed measurement and calculation logic, which is developed based on the assay's chemical characteristics and repeatedly verified with controls and calibrators.
9. How the Ground Truth for the Training Set Was Established:
As explained above, there isn't a "training set" in the machine learning sense. The "ground truth" relevant to the device's operational parameters and calibration would be established through:
- Calibrator materials: These are supplied with known values. The "calibration curve" is generated by the instrument using these calibrators and a master curve provided with the reagent bar code. These calibrator values are derived from rigorously tested and traceable reference materials.
- Quality control materials: Used to continually verify the accuracy and precision of the instrument.
{0}------------------------------------------------
JUL 13 2007
510(k) Summary According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Submitter Roche Diagnostics name, address, 9115 Hague Road contact Indianapolis, IN 46250 (317) 521 - 3544 Contact Person: Kay A. Taylor Date Prepared: July 9, 2007 Device Name Proprietary name: Elecsys PTH Immunoassay Elecsys PTH STAT Immunoassay Common name: Parathyroid Hormone Assay Classification name: Radioimmunoassay, Parathyroid Hormone Device The Elecsys PTH and Elecsys PTH STAT Assays are two step sandwich Description immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code. Intended The Elecsys PTH Immunoassay is for the in vitro quantitative determination use/Indications of intact parathyroid hormone in human serum and plasma as an aid in the for Use differential diagnosis of hypercalcemia and hypocalcemia and can be used intraoperatively. The Elecsys PTH STAT Immunoassay is for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia and can be used intraoperatively. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and cobas e immunoassay analyzers.
{1}------------------------------------------------
510(k) Summary, Continued
| Substantialequivalence | The Elecsys PTH and Elecsys PTH STAT Test Systems are substantiallyequivalent to other devices legally marketed in the United States. The ElecsysPTH and Elecsys PTH STAT Immunoassays (expanded intended use) areequivalent to the Elecsys Parathyroid Hormone Test System (K992680). |
|---|---|
| DeviceComparisonTable | The following table compares the Elecsys PTH and Elecsys PTH STAT TestSystems and the predicate device. The predicate labeling used as the sourcedocument for the comparison is that provided to FDA in K961481/A003. |
..
Comparison Table
| Feature | Predicate DeviceElecsys PTH Assay(K992680) | Modified DeviceElecsys PTH(18 minute appl.) | Modified DeviceElecsys PTH STAT(9 minute appl.) |
|---|---|---|---|
| IntendedUse/Indicationsfor Use | Immunoassay for the invitro quantitativedetermination of intactparathyroid hormone inhuman serum and plasmafor the differential diagnosisof hypercalcemia andhypocalcemia. | The Elecsys PTHImmunoassay is for the invitro quantitativedetermination of intactparathyroid hormone inhuman serum and plasmaas an aid in the differentialdiagnosis ofhypercalcemia andhypocalcemia and can beused intraoperatively. | The Elecsys PTH STATImmunoassay is for the invitro quantitativedetermination of intactparathyroid hormone inhuman serum and plasmafor the differentialdiagnosis ofhypercalcemia andhypocalcemia and can beused intraoperatively. |
| Assay Protocol | Sandwich assay | Same | Same |
| Detection Protocol | ElectrochemiluminescentImmunoassay | Same | Same |
| Feature | Predicate DeviceElecsys PTH Assay(K992680) | Modified DeviceElecsys PTH(18 minute appl.) | Modified DeviceElecsys PTH STAT(9 minute appl.) |
| Platform(s) | Elecsys 1010, Elecsys 2010,MODULAR ANALYTICSE170, cobas e 411 andcobas e 601 analyzers.Note: The cobas eanalyzers are clearedplatforms. Labelingincluding these analyzerswill be manufactured asexisting inventories of theproduct are depleted. | Elecsys 2010,MODULARANALYTICS E170,cobas e 411 and cobas e601 analyzers. | Elecsys 1010, Elecsys2010 and cobas e 411 |
| Total AssayDuration | Elecsys 1010: 9 minuteapplicationElecsys 2010, cobas e 411MODULAR ANALYTICSE170, and cobas e 601: 18minute application | 18 minute | 9 minute |
| Sample Type | Human serum and plasmatreated with K3-EDTA. | Same | Same |
| Calibrator | Elecsys PTH CalSet | Same | Elecsys PTH STATCalSet |
| Reagent Stability | Unopened:2-8°C – Up to the statedexpiration dateOpened:2-8°C – 12 weeksOn the E170/cobas e 601and Elecsys 2010/cobas e411:8 weeksOn the Elecsys 1010:4 weeks (stored alternatelyin the refrigerator and on theanalyzer- ambienttemperature 20-25°C; up to20 hours opened in total.) | Unopened:2-8°C- Up to the statedexpiration dateOpened:2-8°C-12 weeksOn the E170/cobas e 601and Elecsys 2010/cobas e411:- 8 weeks | Unopened:2-8°C- Up to the statedexpiration dateOpened:2-8°C – 12 weeksOn Elecsys 2010 andcobas e 411:8 weeksOn Elecsys 1010:4 weeks (storedalternately in therefrigerator and on theanalyzer- ambienttemperature 20-25°C; upto 20 hours opened intotal.) |
| Measuring Range | 1.20 – 5,000 pg/mL | Same | Same |
| Analyticalsensitivity (LDL) | 1.20 pg/mL(0.127 pmol/L) | Same | Same |
| Feature | Predicate DeviceElecsys PTH Assay(K992680) | Modified DeviceElecsys PTH(18 minute appl.) | Modified DeviceElecsys PTH STAT(9 minute appl.) |
| AnalyticalSpecificity | For the monoclonalantibodies used, thefollowing cross-reactivitieswere found: Osteocalcin,PTH fragment 1-37, bone-specific alkalinephosphatase, and β--Crosslaps: no cross-reactivity detectable. | Same -- reworded to bemore clearNo cross-reactivities werefound for: Osteocalcin,PTH fragment 1-37,bone-specific alkalinephosphatase, and β-CrossLaps. | Same -- reworded to bemore clearNo cross-reactivities werefound for: Osteocalcin,PTH fragment 1-37,bone-specific alkalinephosphatase, and β-CrossLaps. |
| Traceability /Standardization | This method has beenstandardized against acommercially available PTHtest (RIA). | Same -- slightly wordingchange.This method has beenstandardized against acommercial PTH test(RIA). | This method has beenstandardized againstElecsys PTH. This in turnwas standardized against acommercial PTH test(RIA). |
| Hook Effect | No high dose hook effect atPTH concentrations up to17,000 pg/mL. | Same | Same |
| CalibrationInterval | Calibration must beperformed once per reagentlot using fresh reagent (i.e.not more than 24 hours sincethe reagent kit wasregistered on the analyzer).Renewed calibration isrecommended as follows:E170/cobas e 601 andElecsys 2010/cobas e 411:After 1 month (28 days)when using the same reagentlot.After 7 days (when using thesame reagent kit on theanalyzer).Elecsys 1010:With every reagent kit.After 7 days (20-25°C).After 3 days (25-32°C). | Calibration must beperformed once perreagent lot using freshreagent (i.e. not more than24 hours since the reagentkit was registered on theanalyzer). Renewedcalibration isrecommended as follows:E170/cobas e 601 andElecsys 2010/cobas e 411:After 1 month (28 days)when using the samereagent lot.After 7 days (when usingthe same reagent kit onthe analyzer). | Calibration must beperformed once perreagent lot using freshreagent (i.e. not more than24 hours since the reagentkit was registered on theanalyzer). Renewedcalibration isrecommended as follows:E170/cobas e 601 andElecsys 2010/cobas e 411:After 1 month (28 days)when using the samereagent lot.After 7 days (when usingthe same reagent kit onthe analyzer).Elecsys 1010:With every reagent kit.After 7 days (20-25°C).After 3 days (25-32°C). |
| Feature | Predicate DeviceElecsys PTH Assay(K992680) | Modified DeviceElecsys PTH(18 minute appl.) | Modified DeviceElecsys PTH STAT(9 minute appl.) |
| Precision | Elecsys 1010/ 2010: | Elecsys 2010/cobas e411: | Elecsys 1010: |
| Within-run | Within-run | Within-run | |
| Mean | Mean | Mean | |
| 5.4% CV @30.0 pg/mL | 2.7% CV @26.7 pg/mL | 5.4% CV @30.0 pg/mL | |
| 4.0% CV @62.2 pg/mL | 1.6% CV @52.5 pg/mL | 4.0% CV @62.2 pg/mL | |
| 4.0% CV @271 pg/mL | 1.5% CV @261 pg/mL | 4.0% CV @271 pg/mL | |
| 5.8% CV @44.3 pg/mL | 4.1% CV @20.2 pg/mL | 5.8% CV @44.3 pg/mL | |
| 3.4% CV @161 pg/mL | 2.2% CV @58.0 pg/mL | 3.4% CV @161 pg/mL | |
| 3.9% CV @702 pg/mL | 1.9% CV @676 pg/mL | 3.9% CV @702 pg/mL | |
| Total | Total | Total | |
| Mean | Mean | Mean | |
| 5.9% CV @30.0 pg/mL | 6.5% CV @26.7 pg/mL | 5.9% CV @30.0 pg/mL | |
| 4.3% CV @62.2 pg/mL | 3.9% CV @52.5 pg/mL | 4.3% CV @62.2 pg/mL | |
| 4.3% CV @271 pg/mL | 3.0% CV @261 pg/mL | 4.3% CV @271 pg/mL | |
| 7.1% CV @44.3 pg/mL | 6.2% CV @20.2 pg/mL | 7.1% CV @44.3 pg/mL | |
| 5.0% CV @161 pg/mL | 4.1% CV @58.0 pg/mL | 5.0% CV @161 pg/mL | |
| 5.4% CV @702 pg/mL | 2.6% CV @676 pg/mL | 5.4% CV @702 pg/mL | |
| E170: | E170/ cobas e601: | Elecsys 2010/cobas e411: | |
| Within-run | Within-run | Within-run | |
| Mean | Mean | Mean | |
| 2.0% CV @25.0 pg/mL | 2.0% CV @21.9 pg/mL | 2.1% CV @53.4 pg/mL | |
| 1.2% CV @39.8 pg/mL | 1.2% CV @35.0 pg/mL | 1.7% CV @215 pg/mL | |
| 1.1% CV @139 pg/mL | 1.1% CV @123 pg/mL | 1.7% CV @980 pg/mL | |
| 2.2% CV @82.2 pg/mL | 2.2% CV @72.7 pg/mL | 1.6% CV @52.6 pg/mL | |
| 2.8% CV @265 pg/mL | 2.8% CV @236 pg/mL | 2.0% CV @182 pg/mL | |
| 0.6% CV @1,215 pg/mL | 0.6% CV @1,092 pg/mL | 1.8% CV @744 pg/mL | |
| Within-run | Within-run | Within-run | |
| Mean | Mean | Mean | |
| 3.4% CV @26.4 pg/mL | 3.4% CV @23.2 pg/mL | 3.8% CV @53.4 pg/mL | |
| 2.5% CV @91.5 pg/mL | 2.5% CV @80.9 pg/mL | 2.8% CV @215 pg/mL | |
| 2.8% CV @269 pg/mL | 2.8% CV @240 pg/mL | 2.5% CV @980 pg/mL | |
| 1.7% CV @82.7 pg/mL | 1.7% CV @73.0 pg/mL | 1.9% CV @52.6 pg/mL | |
| 1.6% CV @267 pg/mL | 1.6% CV @238 pg/mL | 2.5% CV @182 pg/mL | |
| 1.6% CV @1,222 pg/mL | 1.6% CV @1,098 pg/mL | 2.2% CV @744 pg/mL | |
| Feature | Predicate DeviceElecsys PTH Assay(K992680) | Modified DeviceElecsys PTH(18 minute appl.) | Modified DeviceElecsys PTH STAT(9 minute appl.) |
| Limitations | The assay is unaffected by:Icterus (bilirubin <1,112µmol/L or <65 mg/dLhemolysis (Hb < 0.932mmol/L or < 1.5 g/dL),Lipemia (Intralipid< 1,500 mg/dL)Biotin (<205 nmol/L or< 50 ng/mL) | Do not analyze samplesthat show visible signsof hemolysis. The assayis affected by hemolysis> or equal to 0.10 g/dL.For PTH results < 50pg/mL, hemolysis (Hg<0.0932 mmol/L or ≥0.10g/dL) can lead to areduction oby 3 to 5pg/mL. For PTH results ≥50 pg/mL, hemolysis(Hg< 0.0932 mmol/L or≥0.15 g/dL)affect theresults by less than 10percent.The assay is unaffectedby icterus (bilirubin<1,112 µmol/L or <65mg/dL), lipemia(Intralipid < 1,500mg/dL), biotin (<205nmol/L or < 50 ng/mL). | Do not analyze samplesthat show visible signsof hemolysis. The assayis affected by hemolysis> or equal to 0.25 g/dL.The assay is unaffectedby icterus (bilirubin<1,112 µmol/L or <65mg/dL), lipemia(Intralipid < 1,500mg/dL), biotin (<205nmol/L or < 50 ng/mL). |
| In patients receivingtherapy with high biotindoses (i.e > 5 mg/day), nosample should be takenuntil at least 8 hours afterthe last biotinadministrationNo interference wasobserved from rheumatoidfactors up to aconcentration of 1,500IU/mLIn vitro tests wereperformed on 16 commonlyused pharmaceuticals. Nointerference with the assaywas found. As with all testscontaining monoclonalmouse antibodies,erroneous findings may beobtained from samplestaken from patients whohave been tested withmonoclonal mouseantibodies or have receivedthem for diagnosticpurposes. | Same | Same | |
| Feature | Predicate DeviceElecsys PTH Assay(K992680) | Modified DeviceElecsys PTH(18 minute appl.) | Modified DeviceElecsys PTH STAT(9 minute appl.) |
| Limitations,continued | In rare cases, interferencedue to extremely high titersof antibodies to rutheniumcan occur. The testcontains additives whichminimize these effects.Extremely high titers ofantibodies to streptavidincan occur in isolated casesand cause interference.For diagnostic purposes, theresults should always beassessed in conjunctionwith the patient's medicalhistory, clinicalexamination and otherfindings | Same | Same |
{2}------------------------------------------------
{3}------------------------------------------------
:
.
{4}------------------------------------------------
. .
21
{5}------------------------------------------------
and the state of the state 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 sta
.
{6}------------------------------------------------
:
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 3 2007
Roche Diagnostics Corp. c/o Ms. Kay Taylor Regulatory Affairs Principal 9115 Hague Road P.O. Box 50457 Indianaoplis, IN 46250-0457
Re: K070709
Trade/Device Name: Elecsys PTH Immunoassay and Elecsys PTH STAT Immunoassay Regulation Number: 21 CFR $862.1545 Regulation Name: Parathyroid hormone test system. Regulatory Class: Class II Product Code: CEW Dated: June 18, 2007 Received: June 20, 2007
Dear Ms. Taylor:
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).
{8}------------------------------------------------
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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Sean M. Cooper, M.S., 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
{9}------------------------------------------------
Indication for Use
510(k) Number (if known): K070709
Device Name: Elecsys PTH Immunoassay and Elecsys PTH STAT Immunoassay
Indication For Use:
Elecsys PTH Immunoassay:
The Elecsys PTH: Immunoassay for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. The Elecsys PTH assay can be used intraoperatively.
Elecsys PTH STAT Immunoassay:
The Elecsys PTH STAT: Immunoassay for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. The Elecsys PTH STAT assay can be used intraoperatively.
Prescription Use XXXX (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol Benem
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K070709
§ 862.1545 Parathyroid hormone test system.
(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.